Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial
Introduction Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a 30-day readmission rate of 20%. This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/12/1/e002698.full |
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| author | Nicholas Hart Louise Rose Abdel Douiri Georgios Kaltsakas Eui-Sik Suh Patrick B Murphy Anne Rossel Rebecca F D'Cruz |
| author_facet | Nicholas Hart Louise Rose Abdel Douiri Georgios Kaltsakas Eui-Sik Suh Patrick B Murphy Anne Rossel Rebecca F D'Cruz |
| author_sort | Nicholas Hart |
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| description | Introduction Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a 30-day readmission rate of 20%. This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects of home high-flow therapy (HFT) in addition to usual medical therapy, in eucapnic patients recovering from AECOPD to support the design of a phase 3 trial.Methods A mixed-methods feasibility randomised controlled trial (quantitative primacy, concurrently embedded qualitative evaluation) (ISRCTN15949009) recruiting consecutive non-obese patients hospitalised with AECOPD not requiring acute non-invasive ventilation. Participants were randomised to receive usual care or usual care and home HFT (37°C, 30 L/min) with weekly home-based follow-up for 4 weeks to collect data on: device usage, breathlessness (modified Borg scale, visual analogue scale, Multidimensional Dyspnoea Profile), health-related quality of life (COPD Assessment Test (CAT), Clinical COPD Questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semistructured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, and no device-related serious adverse events (SAE).Results 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, body mass index 23±5 kg/m2, forced expiratory volume in 1 second 32±12%). One withdrew following non-respiratory hospitalisation. Complete outcome measures were collected in >90% of home assessments. There were no device-related SAE. Daily HFT usage was 2.7±2.2 hours in week 1, falling to 2.3±1.4 hours by week 4. Temperature and flow settings were modified for comfort in 6 cases. Higher HFT usage was associated with lower symptom burden (CAT p=0.01). Interviews highlighted ease of device use, reduced salbutamol usage, and improved sputum production and clearance.Conclusions The data from this feasibility study support the progression to a phase 3 randomised clinical trial investigating the effect of home (HFT) on admission-free survival in COPD patients recovering from a severe exacerbation.Trial registration number The study received ethical approval (REC19/LO/0194) and was prospectively registered (ISRCTN15949009). |
| format | Article |
| id | doaj-art-519330d3353e42e7b907736cb1da5a09 |
| institution | Kabale University |
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| publishDate | 2025-01-01 |
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| spelling | doaj-art-519330d3353e42e7b907736cb1da5a092025-01-07T07:00:13ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392025-01-0112110.1136/bmjresp-2024-002698Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trialNicholas Hart0Louise Rose1Abdel Douiri2Georgios Kaltsakas3Eui-Sik Suh4Patrick B Murphy5Anne Rossel6Rebecca F D'Cruz7Lane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKKing`s College London Florence Nightingale School of Nursing and Midwifery, London, UKSchool of Population Health and Environmental Sciences, King`s College London, London, UKLane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKLane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKLane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKLane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKLane Fox Clinical Respiratory Physiology Research Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKIntroduction Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a 30-day readmission rate of 20%. This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects of home high-flow therapy (HFT) in addition to usual medical therapy, in eucapnic patients recovering from AECOPD to support the design of a phase 3 trial.Methods A mixed-methods feasibility randomised controlled trial (quantitative primacy, concurrently embedded qualitative evaluation) (ISRCTN15949009) recruiting consecutive non-obese patients hospitalised with AECOPD not requiring acute non-invasive ventilation. Participants were randomised to receive usual care or usual care and home HFT (37°C, 30 L/min) with weekly home-based follow-up for 4 weeks to collect data on: device usage, breathlessness (modified Borg scale, visual analogue scale, Multidimensional Dyspnoea Profile), health-related quality of life (COPD Assessment Test (CAT), Clinical COPD Questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semistructured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, and no device-related serious adverse events (SAE).Results 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, body mass index 23±5 kg/m2, forced expiratory volume in 1 second 32±12%). One withdrew following non-respiratory hospitalisation. Complete outcome measures were collected in >90% of home assessments. There were no device-related SAE. Daily HFT usage was 2.7±2.2 hours in week 1, falling to 2.3±1.4 hours by week 4. Temperature and flow settings were modified for comfort in 6 cases. Higher HFT usage was associated with lower symptom burden (CAT p=0.01). Interviews highlighted ease of device use, reduced salbutamol usage, and improved sputum production and clearance.Conclusions The data from this feasibility study support the progression to a phase 3 randomised clinical trial investigating the effect of home (HFT) on admission-free survival in COPD patients recovering from a severe exacerbation.Trial registration number The study received ethical approval (REC19/LO/0194) and was prospectively registered (ISRCTN15949009).https://bmjopenrespres.bmj.com/content/12/1/e002698.full |
| spellingShingle | Nicholas Hart Louise Rose Abdel Douiri Georgios Kaltsakas Eui-Sik Suh Patrick B Murphy Anne Rossel Rebecca F D'Cruz Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial BMJ Open Respiratory Research |
| title | Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial |
| title_full | Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial |
| title_fullStr | Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial |
| title_full_unstemmed | Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial |
| title_short | Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial |
| title_sort | home high flow therapy during recovery from severe chronic obstructive pulmonary disease copd exacerbation a mixed methods feasibility randomised control trial |
| url | https://bmjopenrespres.bmj.com/content/12/1/e002698.full |
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