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Meta-Analysis
. 2021 Aug 9;8(8):CD002878.
doi: 10.1002/14651858.CD002878.pub3.

Chronic non-invasive ventilation for chronic obstructive pulmonary disease

Tim Raveling  1   2 , Judith Vonk  2   3 , Fransien M Struik  1 , Roger Goldstein  4 , Huib Am Kerstjens  1   2 , Peter J Wijkstra  1   2 , Marieke L Duiverman  1   2
Affiliations
Meta-Analysis

Chronic non-invasive ventilation for chronic obstructive pulmonary disease

Tim Raveling et al. Cochrane Database Syst Rev. .

Abstract

Background: Chronic non-invasive ventilation (NIV) is increasingly being used to treat people with COPD who have respiratory failure, but the evidence supporting this treatment has been conflicting.

Objectives: To assess the effects of chronic non-invasive ventilation at home via a facial mask in people with COPD, using a pooled analysis of IPD and meta-analysis.

Search methods: We searched the Cochrane Airways Register of Trials, MEDLINE, Embase, PsycINFO, CINAHL, AMED, proceedings of respiratory conferences, clinical trial registries and bibliographies of relevant studies. We conducted the latest search on 21 December 2020.

Selection criteria: We included randomised controlled trials (RCTs) comparing chronic NIV for at least five hours per night for three consecutive weeks or more (in addition to standard care) versus standard care alone, in people with COPD. Studies investigating people initiated on NIV in a stable phase and studies investigating NIV commenced after a severe COPD exacerbation were eligible, but we reported and analysed them separately. The primary outcomes were arterial blood gases, health-related quality of life (HRQL), exercise capacity (stable COPD) and admission-free survival (post-exacerbation COPD). Secondary outcomes for both populations were: lung function, COPD exacerbations and admissions, and all-cause mortality. For stable COPD, we also reported respiratory muscle strength, dyspnoea and sleep efficiency.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. After inclusion of a study, we requested the IPD. We analysed continuous and time-to-event data using linear- and cox-regression mixed-effect models with a random effect on study level. We analysed dichotomous IPD using generalised estimating equations. We adjusted all models for age and sex. We assessed changes in outcomes after three and 12 months. We also conducted a meta-analysis on aggregated trial data.

Main results: We included 14 new RCTs in this review update, in addition to the seven previously included. Seventeen studies investigated chronic NIV in stable COPD and four studies investigated chronic NIV commenced after a severe COPD exacerbation. Three studies compared NIV to sham continuous positive airway pressure (2 to 4 cmH2O). Seven studies used a nasal mask, one study used an oronasal mask and eight studies used both interfaces. Five studies did not report the interface. The majority of trials (20/21) were at high risk of performance bias due to an unblinded design. We considered 11 studies to have a low risk of selection bias and 13 to have a low risk of attrition bias. We collected and analysed the IPD from 13 stable COPD studies (n = 778, 68% of the participants included) and from three post-exacerbation studies (n = 364, 96% of the participants included). In the stable COPD group, NIV probably results in a minor benefit on the arterial partial pressure of oxygen (PaO2) after three months (adjusted mean difference (AMD) 0.27 kPa, 95% CI 0.04 to 0.49; 9 studies, 271 participants; moderate-certainty evidence), but there was little to no benefit at 12 months (AMD 0.09 kPa, 95% CI -0.23 to 0.42; 3 studies, 171 participants; low-certainty evidence). The arterial partial pressure of carbon dioxide (PaCO2) was reduced in participants allocated to NIV after three months (AMD -0.61 kPa, 95% CI -0.77 to -0.45; 11 studies, 475 participants; high-certainty evidence) and persisted up to 12 months (AMD -0.42 kPa, 95% CI -0.68 to -0.16; 4 studies, 232 participants; high-certainty evidence). Exercise capacity was measured with the 6-minute walking distance (minimal clinical important difference: 26 m). There was no clinically relevant effect of NIV on exercise capacity (3 months: AMD 15.5 m, 95% CI -0.8 to 31.7; 8 studies, 330 participants; low-certainty evidence; 12 months: AMD 26.4 m, 95% CI -7.6 to 60.5; 3 studies, 134 participants; very low-certainty evidence). HRQL was measured with the Severe Respiratory Insufficiency and the St. Georges's Respiratory Questionnaire and may be improved by NIV, but only after three months (3 months: standardised mean difference (SMD) 0.39, 95% CI 0.15 to 0.62; 5 studies, 259 participants; very low-certainty evidence; 12 months: SMD 0.15, 95% CI -0.13 to 0.43; 4 studies, 200 participants; very low-certainty evidence). Lastly, the risk for all-cause mortality is likely reduced by NIV (adjusted hazard ratio (AHR) 0.75, 95% CI 0.58 to 0.97; 3 studies, 405 participants; moderate-certainty evidence). In the post-exacerbation COPD group, there was little to no benefit on the PaO2 after three months, but there may be a slight decrease after 12 months (3 months: AMD -0.10 kPa, 95% CI -0.65 to 0.45; 3 studies, 234 participants; low-certainty evidence; 12 months: -0.27 kPa, 95% CI -0.86 to 0.32, 3 studies; 170 participants; low-certainty evidence). The PaCO2 was reduced by NIV at both three months (AMD -0.40 kPa, 95% CI -0.70 to -0.09; 3 studies, 241 participants; moderate-certainty evidence) and 12 months (AMD -0.52 kPa, 95% CI -0.87 to -0.18; 3 studies, 175 participants; high-certainty evidence). NIV may have little to no benefit on HRQL (3 months: SMD 0.25, 95% CI -0.01 to 0.51; 2 studies, 219 participants; very low-certainty evidence; 12 months: SMD 0.25, 95% -0.06 to 0.55; 2 studies, 164 participants; very low-certainty evidence). Admission-free survival seems improved with NIV (AHR 0.71, 95% CI 0.54 to 0.94; 2 studies, 317 participants; low-certainty evidence), but the risk for all-cause mortality does not seem to improve (AHR 0.97, 95% CI 0.74 to 1.28; 2 studies, 317 participants; low-certainty evidence).

Authors' conclusions: Regardless of the timing of initiation, chronic NIV improves daytime hypercapnia. In addition, in stable COPD, survival seems to be improved and there might be a short term HRQL benefit. In people with persistent hypercapnia after a COPD exacerbation, chronic NIV might prolong admission-free survival without a beneficial effect on HRQL. In stable COPD, future RCTs comparing NIV to a control group receiving standard care might no longer be warranted, but research should focus on identifying participant characteristics that would define treatment success. Furthermore, the optimal timing for initiation of NIV after a severe COPD exacerbation is still unknown.

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Conflict of interest statement

T Raveling: none known.

J Vonk: none known.

FM Struik: none known.

R Goldstein: none known.

HAM Kerstjens: none known.

PJ Wijkstra: none known.

ML Duiverman: none known.

Figures

1
1
PRISMA flow diagram
2
2
Risk of bias summary: review authors' judgements about each methodological quality item for each included study Note: blank squares indicate that the outcome domain was not measured in the study.
3
3
The modelled means of the adjusted mixed‐effect models for the primary outcomes, separate for the NIV and the control group, in stable COPD Black triangles: NIV group; red squares: control group. * indicates that the 95% confidence interval of the treatment effect does not cross zero. For the HRQL outcome, a positive value indicates improved HRQL.
4
4
Funnel plot for the PaO2 outcome after 3 months, in participants with stable COPD
5
5
The modelled means of the adjusted mixed‐effect models for the primary outcomes, separate for the NIV and the control group, in post‐exacerbation COPD Black triangles: NIV group; red squares: control group. * indicates that the 95% confidence interval of the treatment effect does not cross zero. For the HRQL outcome, a positive value indicates improved HRQL.
6
6
7
7
1.1
1.1. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 1: Stable COPD: PaO2
1.2
1.2. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 2: Stable COPD: PaCO2
1.3
1.3. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 3: Stable COPD: 6‐minute walking distance
1.4
1.4. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 4: Stable COPD: HRQL
1.5
1.5. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 5: Stable COPD: FEV1
1.6
1.6. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 6: Stable COPD: FVC
1.7
1.7. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 7: Stable COPD: RV/%TLC
1.8
1.8. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 8: Stable COPD: PEmax
1.9
1.9. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 9: Stable COPD: PImax
1.10
1.10. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 10: Stable COPD: Transition Dyspnoea Index
1.11
1.11. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 11: Stable COPD: (modified) Medical Research Council dyspnoea scale
1.12
1.12. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 12: Stable COPD: sleep efficiency
1.13
1.13. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 13: Stable COPD: exacerbations
1.14
1.14. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 14: Stable COPD: hospitalisations
1.15
1.15. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 15: Stable COPD: all‐cause mortality
1.16
1.16. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 16: PaCO2 after 3 months ‐ subgroup PaCO2 (stable COPD)
1.17
1.17. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 17: PaCO2 after 3 months ‐ subgroup IPAP (stable COPD)
1.18
1.18. Analysis
Comparison 1: Comparison 1: NIV vs standard care in stable COPD, Outcome 18: PaCO2 after 3 months ‐ subgroup compliance (stable COPD)
2.1
2.1. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 1: Post‐exacerbation COPD: PaO2
2.2
2.2. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 2: Post‐exacerbation COPD: PaCO2
2.3
2.3. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 3: Post‐exacerbation COPD: HRQL
2.4
2.4. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 4: Post‐exacerbation COPD: admission‐free survival
2.5
2.5. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 5: Post‐exacerbation COPD: FEV1
2.6
2.6. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 6: Post‐exacerbation COPD: FVC
2.7
2.7. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 7: Post‐exacerbation COPD: exacerbations
2.8
2.8. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 8: Post‐exacerbation COPD: hospitalisations
2.9
2.9. Analysis
Comparison 2: Comparison 2: NIV vs standard care in post‐exacerbation COPD, Outcome 9: Post‐exacerbation COPD: all‐cause mortality
See this image and copyright information in PMC

Update of

References

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McEvoy 2009 {published data only}
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Murphy 2017 {published and unpublished data}
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Schneeberger 2017 {published data only}
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Sin 2007 {published data only}
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Struik 2014 {published and unpublished data}
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Strumpf 1991 {published data only}
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Zhou 2017 {published data only}
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References to studies excluded from this review

Ali 2012 {unpublished data only}
    1. Ali M S, Talwar D, Singh M. Nocturnal noninvasive ventilation improves muscle strength in stable COPD patients with respiratory failure DBP - EM:201332. Thorax 2013;67(Suppl 2):A165 (P229).
Chiang 2004 {published data only}
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Clini 1998 {published data only}
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Diaz 1999 {published data only}
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Funk 2011 {published data only}
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Nicolini 2014 {published data only}
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References to studies awaiting assessment

Baturova 2013 {published data only}
    1. Baturova V, Zolotova E, Svet A, Nesterov A, K Dalgatova. Effectiveness of non-invasive ventilation in stable chronic obstructive pulmonary disease with nocturnal desaturation: Prospective open-label randomized parallel-group study. In: European Respiratory Society 23rd Annual Congress; 2013 Sep 7-11; Barcelona. 2013.
Guan 2018 {published data only}
    1. Guan L, Zhou L, Chen R. Home noninvasive ventilation with built-in software in chronic hypercapnic COPD patients: a mid-term prospective, multicenter, randomized, controlled trial. European Respiratory Journal 2018;52((suppl 62)):PA1677. [DOI: 10.1183/13993003.congress-2018.PA1677] - DOI - PMC - PubMed
Xiang 2007 {published data only}
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References to ongoing studies

Ankjaergaard {published data only}
    1. Ankjaergaard KL, Tonnesen P, Laursen LC, Hansen EF, Andreassen HF, Wilcke JT. Home non invasive ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study DBP - 201721. BMC Pulmonary Medicine 2016;16(1):32. - PMC - PubMed
Beth Israel Deaconess Medical Center {published data only}
    1. NCT04210050. Sleep ventilation for patients with advanced hypercapnic COPD [Implementation of a precision sleep ventilation (PSV) chronic respiratory failure management program for patients with advanced hypercapnic COPD]. clinicaltrials.gov/ct2/show/NCT04210050 (first received 24 December 2019).
Gonzales {published data only}
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Lamia {published data only}
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Pepin {published data only}
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References to other published versions of this review

Struik 2013
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