Introduction Patients recovering from severe acute exacerbations of COPD (AECOPD) have a 30-day readmission rate of 25%. High-flow therapy (HFT) improves mucociliary clearance, dead space washout and pulmonary mechanics in stable COPD. This study aimed to determine the feasibility of a Phase III randomised control trial (RCT) of home HFT to improve clinical, patient-reported and physiological outcomes following severe AECOPD.
Methods Mixed-methods feasibility RCT (quantitative primacy, concurrently embedded qualitative evaluation) (NCT03899558). Consecutive hospitalised AECOPD patients, aged 40–80, BMI≤35kg/m2, PaCO2≤7kPa, not requiring acute or home mechanical ventilation were randomised to receive usual care or additional home HFT and received weekly home-based follow-up. Semi-structured interviews were performed in week 4. Feasibility outcomes were recruitment, protocol adherence, device acceptability. Progression criteria: ≥40% of eligible patients randomised, complete data in >70%, no device-related serious adverse events (SAE).
Results Feasibility: Between June 2019–March 2020, 263 patients screened, 45 eligible, 15 declined, 18 (40%) randomised (figure 1). Mean±SD/median(IQR) age 69±5, 44% female, BMI 22.5±5kg/m2, FEV132±12%. Discharge HFT settings: 37°C, 25–30L/min. Adherence to assessments, questionnaires and parasternal EMG (EMGpara) 100%, spirometry 91%, complete data in 83%. By week 4, HFT use was 2.4 hours/day. There were no device-related SAE. Four themes relating to HFT acceptability were identified: technical, daily routine, impact on symptoms, sensory-affective influence. Facilitators to use included device simplicity and sputum clearance, barriers were warmup time and excessive flow/temperature. Exploratory: The HFT group had a 59% risk of 30-day re-exacerbation/readmission (OR 0.41, 95%CI 0.05–3.31). Breathlessness (mBorg) and neural respiratory drive index (EMGpara%max.bpm) improved in the HFT group (admission to week 4 change (Δ) and repeated measures ANOVA significance: Δ-5(-6 to -3),p<0.001 and Δ-214±95%.bpm,p=0.02, respectively), not controls (Δ-2±3,p=0.25 and Δ-207±299%.bpm,p=0.10, respectively). Health status (COPD assessment test) improved in the HFT (Δ-12±5,p<0.001) and control groups (Δ-12±7,p=0.01). Total sleep time fell in the HFT group (Δ-84±97min,p=0.02). There were no changes in physical activity.
Conclusions This study design was determined to be feasible, with all progression criteria met. A Phase III RCT is warranted to evaluate the effects of home high-flow therapy on 30-day re-exacerbation/readmission and patient-reported and physiological outcomes in this high-risk cohort.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.