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Oxygen therapy

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

Evidence review I

NICE Guideline, No. 202

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4229-9

1. Oxygen therapy

1.1. Review question: What is the clinical and cost effectiveness of oxygen therapy adjunctive to ventilatory support for people who do not fulfil long term oxygen therapy (LTOT) criteria for managing obstructive sleep apnoea/hypopnoea syndrome (OSAHS), obesity hypoventilation syndrome (OHS) and COPD-OSAHS overlap syndrome?

1.2. Review Question: What is the clinical and cost effectiveness of oxygen therapy (alone) for managing obstructive sleep apnoea/hypopnoea syndrome (OSAHS), obesity hypoventilation syndrome (OHS) and COPD-OSAHS overlap syndrome?

1.3. Introduction

Oxygen therapy is prescribed for patients with persistent hypoxaemia to increase alveolar oxygen tension and decrease the work of breathing. The concentration of oxygen used to treat hypoxaemia is adjusted to achieve normal or near normal oxygen saturations (94-96%), except in a group of patients with chronic hypercapnia in whom a lower target saturation of 88-92% is required. Patients with obstructive sleep apnoea/hypopnea syndrome, obesity hypoventilation and COPD-OSAHS overlap syndrome all experience varying levels of hypoxaemia. The extent of the hypoxaemia depends on the underlying pathology and patients may have obstructive sleep apnoea/hypopnoea syndrome in combination with chronic obstructive pulmonary disease, or obesity hypoventilation.

Although it is known that peple with OSAHS and OHS suffer hypoxaemia as a consequence of their disease, primary treatment is through the use of CPAP or NIV therapy. The use of ventilatory support reduces periods of apnoea and the work of breathing. However, some patients have persistent hypoxaemia despite the use of ventilatory support. Oxygen therapy is not commonly used in these patients unless they also meet the criteria for long term oxygen therapy (LTOT) as a result of pre-existing chronic respiratory failure with hypoxaemia during wakefulness. The aim of this review question was to determine the clinical and cost effectiveness of oxygen therapy on its own or as an adjunctive to ventilatory support for patients in whom LTOT is not otherwise indicated.

1.4. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of review question oxygen therapy adjunctive to ventilatory support.

Table 1

PICO characteristics of review question oxygen therapy adjunctive to ventilatory support.

Table 2. PICO characteristics of review question oxygen therapy alone.

Table 2

PICO characteristics of review question oxygen therapy alone.

1.5. Clinical evidence

1.5.1. Included studies

Oxygen therapy (with CPAP/non-invasive ventilation)

No relevant clinical studies were identified.

Oxygen therapy (alone)
OSAHS

Three papers from two studies10, 21, 42 were included in this review. These are summarised in Table 3 below.

One study (two papers) was an RCT parallel design and one study was an RCT crossover design. All papers included two comparisons; comparing oxygen therapy alone with CPAP and comparing oxygen therapy alone with a placebo or no treatment.

All studies included a moderate severity population of OSAHS (based on mean AHI). Studies were stratified based on the AHI/ODI severity of the population into mild, moderate or severe OSAHS. When a mixed severity population was included the severity of the majority of the population was used. This was calculated by taking the mean baseline AHI/ODI of the patients included and the study was downgraded for indirectness.

OHS

There was no evidence for people with OHS.

COPD-OSAHS overlap syndrome

There was no evidence for people with COPD-OSAHS overlap syndrome

See also the study selection flow chart in appendix C, study evidence tables in appendix D, Forest plots in appendix E and GRADE tables in appendix H.

1.5.2. Excluded studies

See the excluded studies list in appendix I.

1.5.3. Summary of clinical studies included in the evidence review

Table 3. Summary of studies included in the evidence review for oxygen therapy alone.

Table 3

Summary of studies included in the evidence review for oxygen therapy alone.

1.5.4. Quality assessment of clinical studies included in the evidence review oxygen therapy (alone) – oxygen therapy compared to other interventions/no interventions

Table 4. Clinical evidence summary: Oxygen therapy compared to CPAP (moderate OSAHS).

Table 4

Clinical evidence summary: Oxygen therapy compared to CPAP (moderate OSAHS).

Table 5. Clinical evidence summary: Oxygen therapy compared to Placebo (moderate OSAHS.

Table 5

Clinical evidence summary: Oxygen therapy compared to Placebo (moderate OSAHS.

1.6. Economic evidence

1.6.1. Included studies

No relevant health economic studies were identified.

1.6.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.6.3. Health economic modelling

Original modelling was not conducted for this question.

1.6.4. Health economic evidence statements

No relevant economic evaluations were identified.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The committee considered the outcomes of health-related quality of life and mortality as critical outcomes for decision making. Other important outcomes included sleepiness scores (e.g. Epworth), Apnoea hypopnoea index (AHI), Oxygen desaturation index (ODI), minor adverse effects of treatment, daytime PO2, daytime PCO2, daytime bicarbonate, nocturnal transcutaneous CO2 control, nocturnal oximetry, driving outcomes, neurocognitive outcomes, pulmonary artery pressure by transthoracic echocardiography (TTE), and patient preference. The committee was also interested in the impact on co-existing conditions such as HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension.

No evidence was identified for the outcomes of daytime PCO2, daytime bicarbonate, nocturnal transcutaneous CO2 control, adherence, pulmonary artery pressure by TTE, patient preference and impact on HbA1c for diabetes.

OSAHS
Oxygen therapy + CPAP or non-invasive ventilation vs CPAP or non-invasive ventilation without oxygen therapy

No relevant clinical studies were identified for this comparison.

Oxygen therapy + CPAP or non-invasive ventilation vs any other OSAHS treatment

No relevant clinical studies were identified for this comparison.

Oxygen therapy + CPAP or non-invasive ventilation vs no treatment/sham treatment

No relevant clinical studies were identified for this comparison.

Oxygen therapy vs non-invasive ventilation

No relevant clinical studies were identified for this comparison.

Oxygen therapy (alone) vs CPAP or no treatment

There was evidence from two studies (three papers); both studies had three treatment arms and compared oxygen therapy with CPAP and oxygen therapy with a placebo or no treatment.

One study was an RCT parallel design and one study was a cross over trial with no wash out period which was downgraded for risk of bias. In all studies nocturnal oxygen therapy was administered nightly via nasal cannulae at a rate of 2-4 LPM for between 4-12 weeks duration.

The populations recruited to the studies were predominately male with a diagnosis of OSAHS. One study recruited patients from cardiology practices and only included people with cardiovascular disease or multiple cardiovascular risk factors. The committee considered the applicability of this cohort to the general OSAHS population when making recommendations based on this evidence. At baseline the majority of the study populations had high BMIs and ESS scores under the arbitrary upper limit of normal of 9.

All studies included a mixed OSAHS severity population based on AHI scores. When a mixed severity population was included (i.e. mild and moderate severity OSAHS), the severity of the majority of the population was determined from the mean baseline value and the study was downgraded for indirectness. Based on mean AHI values, both studies were in moderate severity population.

The quality of the evidence varied from low to very low quality; the majority of the evidence was downgraded due to due to risk of bias, indirectness and imprecision. Risk of bias in all studies was due to selection and blinding bias. Indirectness was present in all studies due to the inclusion of mixed severity OSAHS populations, combining people with mild, moderate or severe OSAHS. Imprecision was also present for a number of the outcomes with confidence intervals crossing the MID thresholds. The low quality of evidence and uncertainty around the effect estimate was taken into consideration by the committee when assessing the evidence base in this review.

One study employed a crossover design with no washout period and therefore all outcomes were downgraded for risk of bias and ultimately all outcomes from this study were graded very low quality. The committee however agreed that this study should be included as oxygen therapy should not have any carry over effects and CPAP was administered last to all patients.

The committee considered the clinical importance for AHI on a case by case basis, taking into consideration the baseline AHI and the improvement in severity of sleep apnoea.

OHS

There was no evidence available for people with OHS.

COPD-OSAHS overlap syndrome

There was no evidence available for people with COPD-OSAHS overlap syndrome.

1.7.1.2. Benefits and harms
OSAHS
Oxygen therapy vs CPAP – moderate OSAHS

Across most of the outcomes reported by the 2 studies in this comparison there was no evidence of any clinically important difference between oxygen therapy and CPAP.

Evidence from one study reported a small benefit of CPAP on one aspect of patients QOL. This was based on improvements in the vitality component of their SF-36 score which may be explained by improved sleep quality and cerebral oxygenation, but this did not reach clinical significance.

Evidence from one small study showed a clinically important benefit of CPAP when compared to oxygen therapy for AHI score, although there was large uncertainty around the effect estimate with the confidence interval crossing both MIDs. The committee had expected this result as they did not anticipate any improvements in AHI with oxygen therapy alone, which has been found to lengthen apnoea duration.

The evidence also reported a benefit of CPAP for the neurocognitive outcome (Rey figure – copy). The committee found this unconvincing as neurocognitive outcomes would be more affected by the patients’ sleepiness and vigilance levels and the results would therefore only be valid if the analysis adjusted for baseline sleepiness scores between patients which the study failed to do. The committee also acknowledged the uncertainty around the effect estimate.

The evidence showed a small improvement in ODI change score with oxygen therapy but this change did not meet the threshold of clinically important difference.

The evidence from both studies in this comparison suggested that there were no clinically important differences between oxygen therapy and CPAP for the following outcomes; mortality, adverse events, number of motor vehicle accidents, systolic BP, ODI change scores, Stamford sleepiness scores, SF-36 mental and physical components and the PHQ-9 depression score. There were also no clinically important differences for the remaining nine neurocognitive outcomes reported by one study.

The committee acknowledged the low quality of the evidence, small number of studies and small patient populations. The committee therefore agreed that CPAP is the treatment of choice in patients with moderate OSAHS and noted there was no evidence to suggest oxygen therapy should be recommended as an alternative to CPAP in this population.

Oxygen therapy versus placebo/no treatment - moderate OSAHS

Across most of the outcomes reported by the 2 studies included in this comparison there was no evidence of any clinically important difference between oxygen therapy and a placebo/no treatment.

Evidence from one small study reported a clinically important benefit of oxygen in the ODI change score. The committee however agreed that this finding does not demonstrate any therapeutic benefits of oxygen therapy and merely proves that patients were being given oxygen at that time.

One study reported a reduction in the number of cardiovascular events (including: unstable angina, myocardial infarction, percutaneous coronary intervention for worsening angina and stroke) with oxygen therapy when compared to no treatment. However, although there were no established MIDs for this outcome the committee agreed that the difference was not enough to be of clinical significance, and they also acknowledged the uncertainty around the effect estimate. The committee also noted that this evidence came from a specific cohort of cardiovascular patients so its applicability to a general OSAHS population is limited and should be interpreted with caution.

The evidence showed that there were no clinically important differences between oxygen therapy and placebo/no treatment for the following outcomes: mortality, AHI, number of motor vehicle accidents, systolic BP, Stamford sleepiness scores, QOL outcomes and neurocognitive outcomes.

Overall: oxygen therapy for OSAHS

There was no evidence for oxygen therapy as an adjunct to ventilatory support for people with OSAHS. There was a lack of convincing evidence in favour of oxygen therapy alone for people with moderate OSAHS and no evidence for people with mild and severe OSAHS. There was no overriding consensus within the committee to make a recommendation for oxygen therapy in people with OSAHS. They agreed that a research recommendation, specifically looking at the clinical effectiveness of oxygen therapy compared to a placebo in a CPAP intolerant population, would help to inform future guidance. The committee therefore used consensus opinion to make a research recommendation specifically for this CPAP intolerant OSAHS population as they agreed from their experience that this was a difficult group to manage and further trials on this population could identify if oxygen therapy would be effective.

OHS

There was no evidence for oxygen therapy in OHS.

Based on their experience and current practice, the committee agreed that, whilst optimal CPAP or NIV will usually be sufficient to correct ventilatory failure, some people with OHS may remain hypoxaemic while asleep despite control of AHI and nocturnal hypercapnia. This would be shown on oximetry measures or on arterial blood gas during sleep. Addition of supplemental oxygen therapy to the CPAP or non-invasive ventilation during sleep may be needed to correct this hypoxia and any additional underlying causes of hypoxaemia should be addressed where possible. Usually only a low flow rate such as 1-2L/minute would be required. Repeating oximetry or arterial blood gas would allow the response to this oxygen therapy to be evaluated and any further adjustments to oxygen prescription to be made.

The committee agreed that recommendations on oxygen therapy reflect current practice in most NHS centres, so there is likely to be little impact on practice.

COPD-OSAHS overlap syndrome

The committee noted the lack of evidence for oxygen therapy in COPD-OSAHS overlap syndrome and decided to make consensus recommendations based on experience and current practice.

Some patients will be established users of long-term oxygen therapy because of their COPD, in which case supplemental oxygen can be can be given via CPAP or non-invasive ventilation whilst sleeping, with oxygen flow rate and non-invasive ventilation or CPAP settings titrated during respiratory polygraphy according to individual need. People with COPD-OSAHS are subject to greater falls in oxygen saturation while sleeping than those with COPD alone, and the committee therefore agreed that in people with COPD-OSAHS overlap syndrome who do not fulfil criteria for long term oxygen therapy, supplemental oxygen therapy may be required in those who remain hypoxaemic when asleep despite control of AHI and nocturnal hypercapnia with CPAP or non-invasive ventilation. This would be shown on overnight oximetry measures or on arterial blood gas measurement. Therefore, addition of supplemental oxygen therapy to the CPAP or non-invasive ventilation overnight may be needed to correct this hypoxia and any additional underlying causes of hypoxaemia should be addressed where possible. Usually only low oxygen concentrations such as 1-2L/minute are required. Repeating oximetry or arterial blood gas would allow the response to this oxygen therapy to be evaluated and any further adjustments to oxygen prescription to be made.

The committee noted that the recommendations reflect current practice in most NHS centres, so there is likely to be little impact on practice.

1.7.2. Cost effectiveness and resource use

There were no economic evaluations available for this question.

There was a consensus within the committee that further research was required to establish both the clinical and cost-effectiveness of oxygen therapy for people with OSAHS.

The committee agreed that in people with OHS and COPD-OSAHS overlap syndrome who do not fulfil requirements for long term oxygen therapy, supplemental oxygen therapy would be cost effective in those who remain hypoxaemic at night despite control of AHI with CPAP or NIV. This use of oxygen reflects current practice in most centres.

1.7.3. Other factors the committee took into account

Oxygen therapy may be entrained into a CPAP or NIV device if used in the treatment of patients requiring long term oxygen therapy for COPD as per the NICE guideline NG115 (https://www.nice.org.uk/guidance/ng115) (2018) and NICE quality standard QS10 (https://www.nice.org.uk/guidance/QS10) (2011, updated 2016).

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Appendices

Appendix B. Literature search strategies

Sleep Apnoea search strategy 7 oxygen therapy

This literature search strategy was used for the following review;

  • What is the clinical and cost effectiveness of oxygen therapy adjunctive to ventilatory support for people who do not fulfil long term oxygen therapy (LTOT) criteria for managing obstructive sleep apnoea/hypopnoea syndrome, obesity hypoventilation syndrome and COPD-OSAHS overlap syndrome?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.33

For more information, please see the Methods Report published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 309K)

B.2. Health Economics literature search strategy (PDF, 341K)

Appendix G. Health economic evidence selection

Figure 48. Flow chart of health economic study selection for the guideline (PDF, 228K)

Appendix H. Excluded studies

H.1. Excluded clinical studies

Download PDF (161K)

H.2. Excluded health economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2003 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below:

None.

Appendix I. Research recommendations

I.1. Oxygen therapy (PDF, 143K)

Final

Intervention evidence review

Developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2021.
Bookshelf ID: NBK574328PMID: 34613680

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