Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial
Introduction Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled t...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/7/1/e000694.full |
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| author | Gemma Stanford Diana Bilton Winston Banya Jane C Davies Omar Usmani Susan Charman Mandy Jones Nicholas J Simmonds |
| author_facet | Gemma Stanford Diana Bilton Winston Banya Jane C Davies Omar Usmani Susan Charman Mandy Jones Nicholas J Simmonds |
| author_sort | Gemma Stanford |
| collection | DOAJ |
| description | Introduction Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.Methods and analysis This is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30–60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).Ethics and dissemination Ethics approval was gained from the London–Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.Trial registration numbers ISRCTN11220163 and NCT02721498. |
| format | Article |
| id | doaj-art-1f94608e33704f8f9d5f4f12b0357765 |
| institution | Kabale University |
| issn | 2052-4439 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-1f94608e33704f8f9d5f4f12b03577652024-11-24T07:00:11ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392020-09-017110.1136/bmjresp-2020-000694Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trialGemma Stanford0Diana Bilton1Winston Banya2Jane C Davies3Omar Usmani4Susan Charman5Mandy Jones6Nicholas J Simmonds7Adult Cystic Fibrosis, Royal Brompton Hospital, London, UKRespiratory Medicine, Royal Brompton Hospital, London, UKResearch and Development, Royal Brompton Hospital, London, UK1 Royal Brompton Hospital, London, UKNational Heart and Lung Institute, Imperial College London, London, UKCystic Fibrosis Trust, London, UKBrunel University London, London, UKAdult Cystic Fibrosis, Royal Brompton Hospital, London, UKIntroduction Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.Methods and analysis This is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30–60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).Ethics and dissemination Ethics approval was gained from the London–Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.Trial registration numbers ISRCTN11220163 and NCT02721498.https://bmjopenrespres.bmj.com/content/7/1/e000694.full |
| spellingShingle | Gemma Stanford Diana Bilton Winston Banya Jane C Davies Omar Usmani Susan Charman Mandy Jones Nicholas J Simmonds Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial BMJ Open Respiratory Research |
| title | Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial |
| title_full | Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial |
| title_fullStr | Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial |
| title_full_unstemmed | Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial |
| title_short | Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial |
| title_sort | investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis protocol of a single centre randomised controlled crossover trial |
| url | https://bmjopenrespres.bmj.com/content/7/1/e000694.full |
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