Detailed Study Characteristics

Marina Richardson; Kristen Moulton; Danielle Rabb; Shawn Kindopp; Tushar Pishe; Charles Yan; Ilke Akpinar; Bernice Tsoi; Anderson Chuck

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Richardson M, Moulton K, Rabb D, et al. Capnography for Monitoring End-Tidal CO2 in Hospital and Pre-hospital Settings: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Mar. (CADTH Health Technology Assessment, No. 142.)

APPENDIX 7Detailed Study Characteristics

Research Question 1: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients Undergoing Procedural Sedation

Table 18Study Characteristics for the Included Randomized Controlled Studies for Adult Patients Undergoing Procedural Sedation

First author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting	Procedure Type (n, %); Sedative type (n, %) and Provider of Sedation	Study Procedure		Outcome Measures
First author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting		Intervention Group	Comparator Group	Outcome Measures
Klare 2016⁵¹ Germany RCT	N = 242 Inclusion criteria: - age > 18 years - outpatients and in-patients - scheduled for ERCP - written informed consent Exclusion criteria: - ASA class V - pregnancy - pre-existing hypoxemia (SaO₂ < 90%) - hypotension (SBP < 90 mm Hg) - bradycardia (HR < 50/min)	Three endoscopy centres	Procedure type: ERCP Sedative type: propofol and midazolam Sedative performed by: A physician with experience in intensive care medicine	Standard monitoring + Capnography monitor (Capnostream 20 monitor, Oridion Medical) visible to the treatment team for assessment of ventilation.	Standard monitoring + Capnography monitor (Capnostream 20 monitor, Oridion Medical) not visible to the treatment team for assessment of ventilation.	Primary outcome: Hypoxemia Secondary outcomes: Apnea Vital signs (hypotension - SBP < 90 mm Hg; bradycardia - HR < 50/min) Procedural parameters (sedative dose, duration of procedure) Patient satisfaction Patient cooperation
Van Loon 2014⁶¹ Netherlands RCT	N = 427 Inclusion criteria: - women undergoing minor gynecological procedures - age ≥ 18 years - undergoing deep sedation in an outpatient clinic Exclusion criteria: - ASA classes III to V - allergic reactions to propofol, allergic reactions to soy or egg protein - sleep apnea syndrome	Outpatient clinic in the University Medical Centre	Procedure type: Gynecology procedures (procedures not listed but most of the procedures were abortions) Sedative type: Propofol Alfentanil Sedation performed by: nurses trained in sedation management; doctors with similar training in sedation management provided supervision.	Standard monitoring + Capnography monitor visible (Capnostream 20, Oridion medical) to the treatment team.	Standard monitoring	Primary outcome: Hypoxemia Secondary outcomes: Profound hypoxemia Prolonged hypoxemia Administration of supplemental oxygen Airway interventions Arousal or movement of the patient that interfered with performing the procedure Early termination of the procedure
Friederich-Rust 2014²⁰ Germany RCT	N = 539 Inclusion criteria: - Age ≥ 18 years - Sedation requested during colonoscopy Exclusion criteria: - ASA class IV or V - Pregnant or breastfeeding - Contraindication for colonoscopy - Allergic to propofol, peanuts, soya products, chicken egg protein, sulfite	Endoscopy unit at a university hospital or endoscopy outpatient clinic	Procedure type: Colonoscopy only Colonoscopy + gastroscopy Sedative type: Propofol only Propofol + midazolam Propofol + ketamine Propofol + midazolam + ketamine Sedation performed by: Anesthesiologist* Nurse Internal medicine physician	Standard monitoring + capnography visible (Microcap, Oridion Capnography Inc. Needham MS, US)	Standard monitoring	Primary outcome: Hypoxemia Secondary outcomes: Severe hypoxemia Increase of oxygen supplementation Apnea Time between apnea and hypoxemia Assisted ventilation Bradycardia
Slagelse 2013⁴⁸ Denmark RCT	N = 591 Inclusion criteria: - Age ≥ 18 years - Undergoing endoscopy - Compliant to nurse-administered propofol sedation criteria Exclusion criteria: - ASA physical status classification > III - Sleep apnea - Soy, egg, peanut allergy - BMI > 35 kg/m² - Mallampati score ≥ 4 - Acute gastrointestinal bleeding - Subileus - Gastric retention - Severe cold (30% ≤ FEV₁ < 50%).	Endoscopy department	Procedure type: Upper endoscopy Lower endoscopy Sedative type: Propofol Sedation performed by: Nurses	Standard monitoring + capnography visible (Phillips MP20 monitor; micro stream Capnography)	Standard monitoring	Primary outcome: Hypoxia Secondary outcomes: Actions taken to restore normal ventilation
Beitz 2012³⁸ Germany RCT	N = 760 Inclusion criteria: - Age ≥ 18 years - Presenting for inpatient or outpatient colonoscopy Exclusion criteria: - ASA class IV and V - Allergic to propofol or tape and adhesives - Pregnancy - Pre-existing hypotension (SBP < 90 mm Hg) - Pre-existing bradycardia (HR < 50/min) - Hypoxemia (SaO₂ < 90%) - Need for oxygen supplementation due to pre-existing disease.	Endoscopy unit	Procedure type: Colonoscopy Sedative type: Propofol Sedation performed by: Gastroenterologist	Standard monitoring + Capnography monitor visible (Capnostream 20, Oridion medical) to the treatment team.	Standard monitoring + Capnography monitor not visible to the treatment team.	Primary outcome: oxygen desaturation Secondary outcomes: Apnea abnormal ventilation Hypoxemia Severe hypoxemia Increased oxygen supplementation Assisted ventilation Bradycardia Hypotension Patient cooperation Patient satisfaction Recovery time
Deitch 2010¹⁹ US RCT	N = 132 Inclusion criteria: - Age ≥ 18 years - Required propofol sedation Exclusion criteria: - COPD - Chronic oxygen requirements - Hemodynamic instability - Pregnancy - Allergy to propofol, morphine, or fentanyl (or other components of its formulation) - Procedural sedation could compromise patient safety	Emergency department at a 600-bed teaching hospital	Procedure type: Abscess incision and drainage Fracture reduction Joint reduction Sedative type: Propofol Sedation performed by: Treating physicians in the emergency department	Standard monitoring + Capnography monitor visible (Capnostream 20, Oridion medical) to the treatment team.	Standard monitoring + Capnography monitor not visible to the treatment team.	Primary and secondary outcomes were not explicitly stated. Outcomes: Hypoxia Respiratory depression Hypoventilation Hypoxemia
Qadeer 2009⁵⁴ US RCT	N = 263 Inclusion criteria: - Age ≥ 18 years - Patients undergoing ERCP or EUS in an inpatient or outpatient setting - ASA class I to III Exclusion criteria: - ASA class IV to V - Required emergency procedures - Required monitored anesthesia care sedation - Used oxygen or non-invasive ventilation devices - Allergies to fentanyl, meperidine or midazolam	Endoscopy unit (inpatient or outpatient)	Procedure type: ERCP EUS) Sedative type: Midazolam + meperidine or fentanyl (diazepam was provided when patients were difficult to sedate with the indicated sedation regimen) Sedation performed by: staff physician (endoscopist assessed the depth of sedation)	Standard monitoring + Capnography-based signal (Capnostream 20, Oridion Capnography Inc.) from an independent observer indicating that the patient is “not breathing properly”. Capnography was not visible by the treating team.	Standard monitoring + Capnography-based signal (Capnostream 20, Oridion Capnography Inc.) only when apnea lasts more than 30 seconds (for safety purposes). Capnography was not visible by the treating team.	Primary outcome: Hypoxemia Secondary outcomes: Severe hypoxemia Requirement of supplemental oxygen Apnea Abnormal ventilation

: ASA = American Society of Anesthesiologists; BMI = body mass index; COPD = chronic obstructive pulmonary disease; ERCP = endoscopic retrograde cholangiopancreatography; ETCO₂ = end-tidal carbon dioxide; EUS = endoscopic ultrasonography; FEV₁ = forced expiratory volume in 1 second; HR = heart rate; min = minute; RCT = randomized controlled trial; SaO₂ = oxygen saturation; SBP = systolic blood pressure.

Table 19Study Characteristics for the Included Non-randomized Studies for Adult Patients Undergoing Procedural Sedation

First author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting	Procedure Type (n, %); Sedative type (n, %) and Provider of Sedation	Study Procedure		Outcome Measures
First author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting		Intervention Group	Comparator Group	Outcome Measures
Barnett 2016⁵² US Prospective cohort study (before and after the implementation of capnography)	N = 966 Inclusion criteria: - Outpatients - Undergoing routine colonoscopy (during the specified time frames) - Moderate sedation (with fentanyl and midazolam) - Sufficient understanding of English for the completion of the survey - Room air insufflation Exclusion criteria: - Patients undergoing esophagogastroduodenoscopy	Endoscopy unit	Procedure type: Colonoscopy Sedation type: midazolam and fentanyl Provider of sedation: Unclear (nurses are the only health care provider mentioned in the study)	Standard monitoring + capnography (no device details provided)	Standard monitoring	Primary and secondary outcomes were not explicitly stated. Outcomes: Patient comfort Patient satisfaction Quality of sedation Patient discomfort Oxygen desaturation < 90% or leading to intervention SBP < 90 or > 160 mm Hg HR < 50 or > 120 BPM Hemodynamic or respiratory conditions (that interrupted the procedure) Use of narcotics or reversal drugs Hospitalization (due to sedation-related AE) Usefulness of capnography
Tanaka 2014⁵⁶ US Prospective Cohort	N = 21 Inclusion criteria: - ASA I to III - Age ≥ 18 years - Scheduled to undergo sedation with local or regional anesthesia Exclusion criteria: - Not reported	Unclear	Procedure type: Knee replacement surgery Tumour bone resection Wrist open reduction Sedation type: IV Midazolam and Fentanyl Provider of Sedation: Anesthesiologist or regional anesthesia team	All patients received standard of care (including ETCO₂ monitoring) plus additional study monitors (capnography, brain function monitor, acoustic monitor) that were not visible to the treating clinicians (Capnostream 20, Oridion Capnography, Inc.; Pulse CO-Oximeter with Rainbow Acoustic Monitoring (Rad-87, software v. 7805, Masimo Corp., Irvine CA, US). Waveform and sound files from the capnography and acoustic monitors were retrospectively analyzed.		Primary and secondary outcomes were not explicitly stated. Outcomes: Agreement between capnography and acoustic monitoring for respiratory rate; accuracy of respiratory pause detection.
Schlag 2013⁵⁹ Germany Prospective Cohort	N = 20 Inclusion criteria: - Age ≥ 18 years - Undergoing percutaneous transhepatic cholangiodrainage with sedation Exclusion criteria: - Age < 18 years - ASA class V - Allergic to narcotic drugs - Pregnant - Pre-existing hypotension (systolic blood pressure < 90 mm Hg) - Bradycardia (HR < 50 BPM) - Hypoxemia (SaO₂ < 90%)	Endoscopy unit of an academic centre	Procedure type: Percutaneous transhepatic cholangiodrainage Sedation type: midazolam (IV) and 1% propofol (IV) Provider of Sedation: Physician with experience in intensive care medicine and resuscitation	All patients received standard monitoring + capnography (Capnostream 20, Covidien, US) that was not visible to the treating clinicians. Capnography data were analyzed by an independent observer who was not involved in the procedure		Primary outcome: Duration of detected apnea Secondary outcomes: Apnea Oxygen desaturation Hypoxemia Bradycardia Hypotension Assisted ventilation Number of complications Examiner and patient satisfaction with sedation Recovery time after sedation
Kusunoki 2012⁶⁰ Japan Prospective Cohort	N = 20 Inclusion criteria: - Adults - Undergoing ESD Exclusion criteria: - COPD - ASA class IV or V physical status	University hospital	Procedure type: ESD for superficial esophageal cancer ESD for early gastric cancer Sedation type: IV midazolam and pentazocine (2 received diazepam and haloperidol) Provider of Sedation: Unclear	All patients were monitored with transcutaneous capnography (every 3 seconds, TOSCA 500, Radiometer Basel AG, Basel, Switzerland) and end-tidal capnography (every 5 seconds, Microcap Plus, Oridion Medical Ltd., Needham, MA, US) simultaneously. Recorded data were compared with each other, and compared with respiratory rate and SpO₂, which were also monitored using the capnography device.		Primary and secondary outcomes were not explicitly stated. Outcomes: Agreement between PTCO₂ and ETCO₂ Hypoxia
De Oliveira 2010⁵³ US Prospective Cohort	N = 40 Inclusion criteria: - Women scheduled for hysteroscopy under monitored anesthesia care - Age > 18 years Exclusion criteria: - Age < 18 years - Unwilling to participate - History of lung disease - History of obstructive sleep apnea	Unclear	Procedure type: Hysteroscopy Sedation type: Not reported Provider of sedation: Anesthesia resident or certified registered nurse anesthetist, under the supervision of a faculty attending anesthesiologist	All patients were monitored with transcutaneous capnography (TOSCA 500, Radiometer America Inc., Westlake, OH, US) and ETCO₂ (Capnomac Ultima, Datex-Ohmeda, Madison, WI, US) once the patient reached a Ramsay score ≥ 5. Clinicians were blinded to the transcutaneous capnography monitor values, but ETCO₂ values were visible. Data were recorded by an independent observer and compared with each other.		Primary and secondary outcomes were not explicitly stated. Outcomes: Agreement between PTCO₂ and ETCO₂ Hypoventilation
Cacho 2010⁶² Spain Prospective Cohort	N = 50 Inclusion criteria: - Age ≥ 18 years - Undergoing colonoscopy Exclusion criteria: - Age < 18 years - Mechanical ventilation - History of allergy to sedation and/or analgesia drugs	Outpatient and in-patient	Procedure type: Colonoscopy Sedative type: Pethidine + midazolam Propofol Propofol + fentanyl + midazolam Provider of sedation: Endoscopist and anesthetist oversaw patient sedation; a nurse administered the sedative and analgesics based on direction from the endoscopist.	All patients were monitored by clinical observation as well as with pulse oximetry (Nonin 8600, Medical Inc., Minnesota) and capnography (Microcap, Isso SA. Madrid, Spain) by a nurse beside the patient. Data were compared with each other; however, it is unclear how data were recorded.		Primary and secondary outcomes were not explicitly stated. Outcomes: Hypoventilation Apnea
Deitch 2008⁵⁵ US Prospective cohort (underlying study was an RCT)	N = 110 Inclusion criteria: - Age > 18 years - Receiving propofol for a painful procedure Exclusion criteria: - COPD - Long-term oxygen use - Hemodynamic instability - Respiratory distress - Pregnancy - Allergy to study drugs	Emergency department at a Level I trauma centre medical centre (approximately 75,000 patient visits annually)	Procedure type: Abscess incision and drainage Fracture reduction Joint reduction Sedative type: Propofol Provider of sedation: The provider of sedation was not explicitly stated. However, emergency department personnel were involved in the procedure.	All patients were monitored for vital signs, oxygen saturation and capnography. The treatment team was blinded to ETCO₂ levels. A research assistant recorded ETCO₂ and waveform display data, as well as the treatment team’s ability to recognize respiratory depression. These data were compared with each other.		Primary and secondary outcomes were not explicitly stated. Outcomes: Respiratory depression Adverse events
Deitch 2007⁵⁷ US Prospective cohort (underlying study was an RCT)	N = 80 Inclusion criteria: - Age > 2 years - Receiving fentanyl and midazolam for a painful procedure Exclusion criteria: - Severe COPD - Long-term oxygen use - Hemodynamic instability - Respiratory distress - Pregnancy - Allergy to any of the study drugs	Emergency department at a Level I trauma centre medical centre (approximately 70,000 patient visits annually)	Procedure type: Abscess incision and drainage Fracture or joint reduction Other procedures Sedative type: Intravenous midazolam and fentanyl Provider of sedation: Emergency room physician (orders sedatives and analgesics and performs the procedure) and emergency room nurse (administers the drugs and monitors the patient)	All patients were monitored for vital signs, oxygen saturation, and capnography. The treatment team was blinded to ETCO₂ levels. A research assistant recorded ETCO₂ and waveform display data, as well as the treatment team’s ability to recognize respiratory depression. These data were compared with each other.		Primary and secondary outcomes were not explicitly stated. Outcomes: Respiratory depression Adverse events
Burton 2006⁵⁸ US Prospective Cohort	N = 59 Inclusion criteria: - Adult and pediatric ED patients - Undergoing procedural sedation and analgesia Exclusion criteria: - Study investigators not present for enrolment.	ED of a 500-bed tertiary-care hospital with an ED volume of 52,000 patients per year	Procedure type: Dislocation reduction, shoulder Dislocation reduction, hip Fracture reduction Cardioversion Wound closure Transesophageal echocardiography Tube thoracostomy Disimpaction Foreign body removal Sedative type: Propofol Etomidate Midazolam Ketamine Provider of sedation: unclear: "performed in a fashion consistent with generally accepted guidelines"	All patients were monitored according to sedation guidelines + capnography (multi-parameter monitor (LIFEPAK 12 defibrillator/monitor series, Medtronic Emergency Response Systems, Redmond, WA). The treatment team was blinded to study monitoring data. A study investigator recorded all monitoring data and observations. These data were compared with each other.		Primary and secondary outcomes were not explicitly stated. Outcomes: Clinically important acute respiratory events
Soto 2005⁵⁰ US Prospective Cohort	N = 99 Inclusion criteria: - Scheduled to undergo a procedure with monitored anesthesia care or sedation - Completion of a consent form Exclusion criteria: - Pregnant - Age < 18 years - Unable to maintain an SpO₂ > 88% on room air Note: Patients were excluded from study after enrolment if they: - needed an artificial airway to maintain ventilation - needed artificial ventilation	Large teaching institution (unit or department not specified)	Procedure type: Orthopedic, vascular, pain, and gastroenterology procedures. Sedative type: Most patients received combinations of midazolam, propofol and fentanyl Provider of sedation: anesthesia residents and nurse anesthetists (supervised by faculty anesthesiologists)	All patients were monitored with capnography (NPB-70 hand-held capnometer, Nellcor, Pleasanton), BIS, ECG, SpO₂, and blood pressure every 2.5 minutes. If a patient was experiencing apnea or airway obstruction for 60 seconds, the capnography notified (uncertain if it was an alarm or something else) the anesthesia provider of the event if the event was undetected by the standard monitoring. The anesthesia provider was blinded to both BIS and capnography data.		Primary and secondary outcomes were not explicitly stated. Outcomes: Deepest level of sedation achieved Apnea

: AE = adverse event; ASA = American Society of Anesthesiologists; BIS = bispectral index; BPM = beats per minute; CA = California; ECG = electrocardiogram; COPD = chronic obstructive pulmonary disease; ECG = electrocardiogram; ED = emergency department; ESD = endoscopic mucosal dissection; ETCO₂ = end-tidal carbon dioxide; HR = heart rate; IV = intravenous; PTCO₂ = transcutaneous carbon dioxide; RCT = randomized controlled trial; SBP = systolic blood pressure; SpO₂ = oxygen saturation measured by pulse oximetry; US = United States; WA = Washington

Research Question 2: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients Undergoing Procedural Sedation

Table 20Characteristics for the Included Randomized Controlled Studies for Pediatric Patients Undergoing Procedural Sedation

First author,
Year, Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %) and
Provider of Sedation

Study Procedure

Outcome Measures

Intervention
Group

Comparator
Group

Langhan 2015⁶⁸

US

RCT

N = 154

Inclusion criteria:

-: Children aged 1 to 20 years
-: Received IV medication to induce sedation

Exclusion criteria:

-: Intubation
-: Administration of baseline supplemental oxygen without preceding hypoxemia
-: Conditions associated with abnormal ETCO₂ values, such as lower airway disease (e.g., asthma), diabetic ketoacidosis, moderate to severe dehydration, major trauma
-: Intolerance of the cannula
-: Crying for longer than 20% of sedation

Pediatric emergency department, urban, tertiary care academic centre

Procedure type:
Fracture reduction
Laceration repair
Incision and drainage of abscess
Arthrocentesis
Dislocation
Other

Sedative type:
Ketamine
Midazolam

Sedation performed by:
Provider of sedation was not explicitly stated, although a nurse and physician certified to perform the sedation were present.

Standard monitoring + Capnography monitor (Nellcor OxiMax NPB-75 portable capnograph) visible to treatment team.

Standard monitoring + Capnography monitor not visible to the treatment team.

Primary outcomes:

Hypoventilation without hyperventilation
Staff interventions
Oxygen desaturations

Secondary outcomes:

Persistent hypoventilation
Timely interventions

Lightdale 2006⁶⁵

US

RCT

N = 163

Inclusion criteria:

-: Patients undergoing elective procedures at an outpatient endoscopy unit
-: Age 6 months to 19 years
-: ASA class I to II

Exclusion criteria:

-: ASA class III to V
-: Receiving general anesthesia
-: Required emergency procedures
-: Seizure disorder
-: Use of mood-altering or chronic pain medications

Endoscopy unit (outpatient) at a children's hospital

Procedure type:
Endoscopy
Colonoscopy

Sedative type:
Oral midazolam (some patients), intravenous midazolam, intravenous fentanyl

Sedation performed by:
Provider of sedation was not explicitly stated, though an endoscopist was said to provide the oral midazolam where applicable.

Standard monitoring + Capnography-based signal (Philips M4 with Microstream CO₂, Oridion Medical Inc.) from an independent observer indicated with a raised hand when capnography waveforms were absent for > 15 seconds. Capnography was not visible by the treating team.

Standard monitoring + Capnography-based signal (Philips M4 with Microstream CO₂, Oridion Medical Inc.) from an independent observer indicated with a raised hand when capnography waveforms were absent for > 60 seconds. Capnography was not visible by the treating team.

Primary outcome:

Oxygen desaturation

Secondary outcome:

Abnormal ventilation
Termination of the procedure
Adverse events

: ASA = American Society of Anesthesiologists; BP = blood pressure; BPM = beats per minute; ETCO₂ = end-tidal carbon dioxide; IV = intravenous; RCT = randomized controlled trial.
a: If RCT, sample size is the number of patients randomized.

Table 21Study Characteristics for the Included Non-randomized Studies for Pediatric Patients Undergoing Procedural Sedation

First Author,
Year, Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %)
and Provider of
Sedation

Study Procedure

Outcome Measures

Kannikeswaran 2011⁶⁷

US

Prospective Cohort

N = 150

Inclusion criteria:

-: Children (ages 1 to 10 years)
-: With developmental disability
-: Outpatient
-: Undergoing a brain MRI that required sedation

Exclusion criteria:

-: No developmental disability
-: Not a brain MRI
-: Required general anesthesia
-: ASA ≥ 3
-: Admitted to inpatient unit prior to the MRI
-: Had a condition that did not allow for use of a nasal cannula
-: Previous study enrolment

Imaging department at a tertiary-care children’s hospital (free-standing centre); approximately 2,000 children undergo MRI with sedation per year.

Procedure type:
None — diagnostic

Sedative type:
Pentobarbital
Fentanyl
Midazolam
Chloral hydrate

Provider of sedation:
A team of emergency medicine physicians

All patients were monitored according to sedation guidelines + capnography (N-85 hand-held capnograph/pulse
Oximeter, Nellcor Puritan Bennett Inc., Boulder, CO, US) at baseline and during sedation (Medrad 9500 MRI, Medrad Inc., Warrendale, PA, US). ETCO₂ values were visible by the clinical team but were not used for patient management.

Capnography data were recorded by a research assistant every minute during patient sedation.

Primary and secondary outcomes were not explicitly stated.

Outcomes:

Hypoxia
Acute respiratory event

Anderson 2007⁶⁶

US

Prospective Cohort

N = 125

Inclusion criteria:

-: Age 2 to 17 years
-: Weight > 12 kg
-: ASA class I or II
-: Target fasting time for solids was 5 to 6 hours and 3 to 4 hours for liquids

Exclusion criteria:

-: Airway abnormalities
-: Abnormalities of the cardiorespiratory, hepatic, renal or central nervous system
-: History of allergy or adverse reaction to propofol, opioids, eggs, soy

Tertiary pediatric hospital (annually 40,000 visits to the emergency department)

Procedure type:
Forearm fracture reduction
Tibia/fibula fracture reduction
Humerus fracture reduction
Elbow joint reduction
Hip joint reduction
Shoulder joint reduction

Sedative type:
Propofol

Provider of sedation:
Consisted of a sedation team:
1. Pediatric emergency physician (administered propofol); 2. Orthopedic surgeon (surgery); 3. Registered nurse (recorded vital signs, dose timing, interventions and sedation depth); 4. EMT for airway management assistance.

All patients were monitored continuously by capnography (Portable Capnocheck II, BCI Waukesha, WI)

A research assistant recorded the timing and duration of interventions related to the ETCO₂ measure; it was unclear it the treating physicians were aware of the ETCO₂ measures.

Primary and secondary outcomes were not explicitly stated.

Outcomes:

Adverse respiratory events
Apnea
Adverse airway events
Airway interventions

: ASA = American Society of Anesthesiologists; CO = Colorado; CO₂ = carbon dioxide; EMT = emergency management technician; ETCO₂ = end-tidal carbon dioxide; kg = kilograms; MRI = magnetic resonance imaging; PA = Pennsylvania; US = United States; WI = Wisconsin.

Research Question 3: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients Undergoing Cardiopulmonary Resuscitation

Table 22Study Characteristics for the Included Non-Randomized Studies for Adult Patients Undergoing CPR

First Author,
Year,
Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %)
and Provider of
Sedation

Study Procedure

Outcome Measures

Intervention
Group

Comparator
Group

Chen 2015¹

Taiwan

Retrospective Cohort

n= 1113

Inclusion criteria:

-: Adult patients
-: Alive in 2005
-: Underwent an out-of-hospital cardiac arrest

Exclusion criteria:

-: Patients who did not have documented chest compressions

Patients experiencing an out-of-hospital cardiac arrest (subsequently receiving care in medical centres, regional hospitals, local hospitals and clinics)

Procedure type:
Cardiac arrests

Sedation type: NA

Provider of sedation: NA

Documented use of ETCO₂.

No documented use of ETCO₂.

Not explicitly stated; however, the following outcomes were assessed in the regression models:

Outcomes:

Sustained ROSC
Survival to hospital discharge

: CPR = cardiopulmonary resuscitation; ETCO₂ = end-tidal carbon dioxide; NA = not applicable; ROSC = return of spontaneous circulation.

Research Question 4: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients Undergoing Cardiopulmonary Resuscitation

No data available.

Research Question 5: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients in Serious or Critical Condition

Table 23Study Characteristics for the Included Non-Randomized Studies for Adult Patients in Serious or Critical Condition

First Author,
Year, Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %)
and Provider of
Sedation

Study Procedure

Outcome Measures

Bhat 2014⁶⁹

US

Retrospective
Cohort

n = 169
Inclusion criteria:

-: In the ED for ≥ 2 hours post-intubation (boarding — i.e., waiting for a bed in ICU)
-: Were managed primarily by the ED team

Exclusion criteria:

-: Do-not-resuscitate order
-: Primarily managed by the trauma team
-: Patients who underwent major surgery within six hours of intubation

ED of a large tertiary care hospital

Procedure type:
Intubated patients spending at least 2 hours boarding in the ED

Sedation type: Not reported

Provider of sedation: Not reported

6 post-intubation interventions were variably performed in the ED (chest x-ray, orogastric tube, sedation within 30 minutes, arterial blood gas, appropriate tidal volume, ETCO₂)

All data were retrospectively collected through chart review with patients classified as having received the intervention or not received the intervention.

Primary and secondary outcome measures were not explicitly stated.

Outcomes:

Mortality
Ventilator-associated pneumonia

Silvestri 2005⁷⁰

US

Prospective Cohort

n = 153
Inclusion criteria:

-: Patients arriving at a regional trauma centre ED who underwent out-of-hospital endotracheal intubation

Exclusion criteria:

-: Pronounced dead in the out-of-hospital setting
-: Patients who arrived with bag valve–mask ventilation,
-: Cricothyrotomy, laryngeal mask airway, or Combitube airway device.

ED of a Level 1 trauma centre

Procedure type:
NA (patients arriving at the ED having undergone intubation out of hospital)

Sedation type: Not reported

Provider of sedation: Not reported

ETCO₂ monitoring was used by paramedics at their own discretion following endotracheal intubation in out-of-hospital settings.

Upon arrival at the ED, the use of ETCO₂ was determined and patients were classified as having been monitored by ETCO₂ or not monitored by ETCO₂.

Primary outcome:
unrecognized misplaced endotracheal tube

Secondary outcomes were not explicitly stated.

Other outcomes:

Mortality
Discharge location
Neurological impairment

: ED = emergency department; ETCO₂ = end-tidal carbon dioxide; ICU = intensive care unit; NA = not applicable; US = United States.

Research Question 6: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients in Serious or Critical Condition

Table 24Study Characteristics for the Included Randomized Controlled Studies for Pediatric Patients in Serious or Critical Condition

First Author,
Year, Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %)
and Provider of
Sedation

Study Procedure

Outcome Measures

Intervention
Group

Kong 2013⁷¹

US

RCT

n = 50

Inclusion criteria:

-: Infants (with one of the following: gestational age < 34 weeks, prenatally diagnosed anomalies except airway or lung abnormalities)
-: Receiving positive pressure ventilation with CPAP or ETT

Exclusion criteria:

-: Oligohydramnios (amniotic fluid index < 5) before week 28
-: Suspected hypoplasia of the lungs
-: Congenital conditions (diaphragmatic hernia, airway anomalies, heart disease)

Labour and delivery unit at a medical centre, and adjacent resuscitation room

Procedure type:
NA (newborns with a high risk of needing resuscitation)

Sedation type: NA

Provider of sedation: NA

ETCO₂ was monitored after delivery and the display was visible to the resuscitation team. The team was told to keep ETCO₂ levels between 40 mm Hg and 55 mm Hg by adjusting ventilation as required.

ETCO₂ was monitored after delivery and the display was covered so the resuscitation team could not see it. The team was told to adjust ventilation as required by clinical judgment.

Primary outcome:

Admission (to ICU — approx. 1 hour after birth) PCO₂ values outside of the 40 mm Hg to 60 mm Hg range.

Secondary outcomes:

Duration of ventilation
Oxygen use at 36 weeks
Pneumothorax
Pulmonary interstitial emphysema intraventricular hemorrhage or periventricular leukomalacia
Systemic blood flow
Adjustment of ventilation variables (respiratory rate, positive inspiratory pressure or positive end-expiratory pressure) in the delivery room

Kugelman 2015⁷²

Israel

RCT

n = 66

Inclusion criteria

-: Intubated with a double-lumen endotracheal tube
-: Receiving conventional ventilation
-: Signed informed consent by a parent
-: Expected to be able to provide 3 pairs of readings for PCO₂ and ETCO₂

Exclusion criteria

-: Intubated with a single-lumen ETT
-: Receiving high frequency ventilation

In hospital

University- affiliated tertiary care centre.

Neonatal Intensive Care Units

Procedure type:
N/A (ventilated infants in the neonatal intensive care unit)

Sedation type: NA

Provider of sedation: NA

Capnography data were recorded, visible to the treatment team, and used to guide patient care.

Capnography data were recorded. The capnography monitor was covered, but the capnograph tracing was visible to the medical team to ensure adequate measurements and to change the sampling line.

Primary outcome:

Time spent in a safe CO₂ range (> 30 mm Hg to < 60 mm Hg)

Secondary outcomes were not explicitly stated.

Other outcomes:

Changes in ventilation variables
Number and values of arterial blood gas measurements
number of red blood cell transfusions
Number of chest radiographs

: CO₂ = carbon dioxide; CPAP = continuous positive airway pressure; ED = emergency department; ETCO₂ = end-tidal carbon dioxide; ETT = endotracheal tube; ICU = intensive care unit; NA = not applicable; PCO₂ = partial pressure of carbon dioxide; RCT = randomized controlled trial; US = United States.

Table 25Study Characteristics for the Included Non-Randomized Studies for Pediatric Patients in Serious or Critical Condition

First Author,
Year, Country,
Study Type

Sample Size (n)^a and
Patient Characteristics

Study Setting

Procedure Type (n, %);
Sedative type (n, %)
and Provider of
Sedation

Study Procedure

Outcome Measures

Intervention
Group

Comparator
Group

Hawkes 2015⁷³

Ireland

Prospective Cohort with historical control

n = 92

Inclusion criteria:

-: Infants (< 32 weeks gestation)

Exclusion criteria:

-: Oligohydramnios (amniotic fluid index < 5)
-: Congenital conditions

University maternity hospital

Procedure type:
NA (preterm infants)

Sedation type: NA

Provider of sedation: NA

All infants were monitored with ETCO₂ once they were placed on the resuscitation table. Monitoring continued throughout the stabilization period. The entire period was also monitored with video. The medical team was told to obtain capnographic waveforms but not make adjustments based on the capnometry values displayed.

A historical control group that did not receive ETCO₂ monitoring.

Primary outcome not explicitly stated.

Outcomes:

Comparison between ETCO₂ and PCO₂ values. within the first 10 min of life
Percentage of patients falling within the target PCO₂ range.
Number of patients intubated.

: ETCO₂ = end-tidal carbon dioxide; NA = not applicable; PCO₂ = partial pressure of carbon dioxide

Research Question 7: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

Table 26Study Characteristics for the Included Randomized Controlled Studies for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

First Author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting	Procedure Type (n, %); Sedative type (n, %) and Provider of Sedation	Study Procedure		Outcome Measures
First Author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting		Intervention Group	Comparator Group	Outcome Measures
Hutchison 2008³² US RCT	n = 54 Inclusion criteria: - Age > 18 years - Post-orthopedic surgery - Received a physician order for opioid analgesia - Opioid-naive - Breathing spontaneously (non-ventilated) - No diagnosis of sleep apnea - No CPAP device - Had at least one of the following characteristics: BMI ≥ 30, history of snoring, history in the PACU of one episode of a RR < 10 breaths/minute or a basal (continuous) dosage of IV opioid or oral opioid) - Be able to report their measure of pain intensity Exclusion criteria: Not reported	PACU of a hospital	Procedure type: TKR Bilateral TKR TKR with bone biopsy Hip replacement Shoulder repair Sedation type: Not reported Provider of sedation: Not reported	Patients were monitored continuously using the capnography device (Alaris ETCO₂ module) (Cardinal Health) with Microstream Smart CapnoLine capnography nasal cannula (Oridion)	Patients were monitored every 4 hours by observation or auscultation — assessing pulse oximetry and respiratory rate (standard oxygen cannula)	Primary outcome: Respiratory depression Secondary outcomes: Pauses in breathing during sleep Time in the PACU Distance ambulated on the first post-operative day (measured by the physical therapist) Morphine equivalent consumed (recorded for 36 hours) Pain intensity (measured on a 10-point rating scale)

: BMI = body mass index; CPAP = continuous positive airway pressure; ETCO₂ = end-tidal carbon dioxide; IV = intravenous; PACU = post-anesthesia care unit; RR = respiratory rate; TKR = total knee replacement; US = United States.

Table 27Study Characteristics for the Included Non-Randomized Studies for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

First Author, Year, Country, Study Type	Sample Size (n)^a and Patient Characteristics	Study Setting	Procedure Type (n, %); Sedative type (n, %) and Provider of Sedation	Study Procedure	Outcome Measures
Ramsay 2013⁷⁴ US Prospective Cohort	n = 33 Inclusion criteria: - Adult patients - Presenting to a post-anesthesia care unit following surgery Exclusion criteria: Not reported	Post-anesthesia care unit of an academic tertiary-care facility	Procedure type: Laparoscopic gastric bypass Laparoscopic gastric sleeve Laparoscopic cholecystectomy Herniorrhaphy Cystoscopy and ureteroscopy Other Sedative Type Not reported Provider of Sedation Not reported	All patients were monitored with pulse co-oximeter with rainbow acoustic monitoring technology (RAM) technology (Rad-87, version 7804, Masimo) and capnography (Smart CapnoLine adult CO₂ nasal sampling set with capnostream20 version 4.5, Oridion, Needham, MA.) Data were retrospectively reviewed and manually annotated.	Primary and secondary objectives were not explicitly stated. Outcomes: Ventilatory pause True positive False negative Reliability Drop-outs Lower-bound limits

: CO₂ = carbon dioxide; US = United States.

Research Question 8: Clinical effectiveness of ETCO₂ monitoring for pediatric patients with known obstructive sleep apnea or receiving high doses of opioids in post-operative care

No data available.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK362357

Contents

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APPENDIX 7Detailed Study Characteristics

Research Question 1: Clinical Effectiveness of ETCO2 Monitoring for Adult Patients Undergoing Procedural Sedation

Table 18Study Characteristics for the Included Randomized Controlled Studies for Adult Patients Undergoing Procedural Sedation

Table 19Study Characteristics for the Included Non-randomized Studies for Adult Patients Undergoing Procedural Sedation

Research Question 2: Clinical Effectiveness of ETCO2 Monitoring for Pediatric Patients Undergoing Procedural Sedation

Table 20Characteristics for the Included Randomized Controlled Studies for Pediatric Patients Undergoing Procedural Sedation

Table 21Study Characteristics for the Included Non-randomized Studies for Pediatric Patients Undergoing Procedural Sedation

Research Question 3: Clinical Effectiveness of ETCO2 Monitoring for Adult Patients Undergoing Cardiopulmonary Resuscitation

Table 22Study Characteristics for the Included Non-Randomized Studies for Adult Patients Undergoing CPR

Research Question 4: Clinical Effectiveness of ETCO2 Monitoring for Pediatric Patients Undergoing Cardiopulmonary Resuscitation

Research Question 5: Clinical Effectiveness of ETCO2 Monitoring for Adult Patients in Serious or Critical Condition

Table 23Study Characteristics for the Included Non-Randomized Studies for Adult Patients in Serious or Critical Condition

Research Question 6: Clinical Effectiveness of ETCO2 Monitoring for Pediatric Patients in Serious or Critical Condition

Table 24Study Characteristics for the Included Randomized Controlled Studies for Pediatric Patients in Serious or Critical Condition

Table 25Study Characteristics for the Included Non-Randomized Studies for Pediatric Patients in Serious or Critical Condition

Research Question 7: Clinical Effectiveness of ETCO2 Monitoring for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

Table 26Study Characteristics for the Included Randomized Controlled Studies for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

Table 27Study Characteristics for the Included Non-Randomized Studies for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

Research Question 8: Clinical effectiveness of ETCO2 monitoring for pediatric patients with known obstructive sleep apnea or receiving high doses of opioids in post-operative care

Research Question 1: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients Undergoing Procedural Sedation

Research Question 2: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients Undergoing Procedural Sedation

Research Question 3: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients Undergoing Cardiopulmonary Resuscitation

Research Question 4: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients Undergoing Cardiopulmonary Resuscitation

Research Question 5: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients in Serious or Critical Condition

Research Question 6: Clinical Effectiveness of ETCO₂ Monitoring for Pediatric Patients in Serious or Critical Condition

Research Question 7: Clinical Effectiveness of ETCO₂ Monitoring for Adult Patients With Known Obstructive Sleep Apnea or Receiving High Doses of Opioids in Post-Operative Care

Research Question 8: Clinical effectiveness of ETCO₂ monitoring for pediatric patients with known obstructive sleep apnea or receiving high doses of opioids in post-operative care