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Randomized Controlled Trial
. 2019 Apr 14;6(1):e000399.
doi: 10.1136/bmjresp-2018-000399. eCollection 2019.

Randomised cross-over trial evaluating the short-term effects of non-invasive ventilation as an adjunct to airway clearance techniques in adults with cystic fibrosis

Gemma Stanford  1 , Helen Parrott  2 , Diana Bilton  3 , Penny Agent  2 , Winston Banya  4 , Nicholas Simmonds  1
Affiliations
Randomized Controlled Trial

Randomised cross-over trial evaluating the short-term effects of non-invasive ventilation as an adjunct to airway clearance techniques in adults with cystic fibrosis

Gemma Stanford et al. BMJ Open Respir Res. .

Abstract

Introduction: Non-invasive ventilation (NIV) is used in cystic fibrosis (CF) to support airway clearance techniques (ACTs) by augmenting tidal volumes and reducing patient effort. However, the evidence base for this is limited. We hypothesised that NIV, in addition to usual ACT, would increase sputum clearance. In addition, we investigated ease of sputum clearance (EoC), work of breathing (WoB) and NIV tolerability.

Methods: Adults with CF (16+ years) at the end of hospitalisation for a pulmonary exacerbation were randomised to a cross-over trial of NIV-supported ACT or ACT alone in two consecutive days. No other changes to standard care were made. The primary outcome was the total 24-hour expectorated sputum wet weight after the intervention. Spirometry was completed pre-treatment and post-treatment. Oxygen saturations were measured pre-treatment, during treatment and post-treatment. EoC and WoB were assessed using Visual Analogue Scale.

Results: 14 subjects completed the study (7 male, mean age 35 [SD 17] years, mean forced expiratory volume in 1 s [FEV1] 49 [20] % predicted). The difference between treatment regimens was -0.98 g sputum (95% CI -11.5 to 9.6, p=0.84) over 24 hours. During treatment oxygen saturations were significantly higher with NIV-supported ACT (mean difference 2.0, 95% CI 0.9 to 2.6, p=0.0004). No other significant differences were found in post-treatment FEV1, EoC, WoB, oxygen saturations or subject preference.

Conclusions: There was no difference in treatment effect between NIV-supported ACT and ACT alone, although the study was underpowered. Oxygen saturations were significantly higher during NIV-supported ACT, but with no effect on post-treatment saturations. NIV was well tolerated.

Trial registration number: NCT01885650.

Keywords: airway clearance; cystic fibrosis; non-invasive ventilation; physiotherapy.

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Conflict of interest statement

Competing interests: NS has consulted for Vertex Pharmaceuticals, Chiesi, Roche, Pulmocide, PTC Therapeutics and Gilead.

Figures

Figure 1
Figure 1
CONSORT diagram of the study. ACT, airway clearance technique; CONSORT, Consolidated Standards of Reporting Trials; 1; NIV, non-invasive ventilation.
Figure 2
Figure 2
Oxygen saturation during treatment. ACT, airway clearance technique; NIV, non-invasive ventilation.
See this image and copyright information in PMC

References

    1. CF Trust 2017 annual report Reporting and resources, 2018. Available: https://www.cysticfibrosis.org.uk/the-work-we-do/uk-cf-registry/reportin...
    1. Zach MS. Lung disease in cystic fibrosis--an updated concept. Pediatr Pulmonol 1990;8:188–202. 10.1002/ppul.1950080311 - DOI - PubMed
    1. Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med 1995;151:939–41. 10.1164/ajrccm/151.4.939 - DOI - PubMed
    1. Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol 1997;24:137–42. 10.1002/(SICI)1099-0496(199708)24:2<137::AID-PPUL13>3.0.CO;2-3 - DOI - PubMed
    1. CF Trust CF trust Factsheet – physiotherapy treatment in cystic fibrosis: airway clearance techniques. CF trust website, 2011. Available: www.cysticfibrosis.org.uk/media/127518/FS_Physiotherapy_Airway_Clearance...

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