Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial

Abstract

IntroductionEarly pulmonary rehabilitation is recommended after a severe exacerbation of chronic obstructive pulmonary disease (COPD). However, this is difficult to implement, particularly for exercise training. High-flow nasal therapy (HFNT) may reduce the work of breathing and dyspnoea and may improve exercise tolerance.Methods and analysisThis is a single-centre, prospective, controlled, randomised, cross-over study. Eligible patients will have a diagnosis of COPD (postbronchodilator forced expiratory volume in 1 s/forced vital capacity ratio of <0.7). Two constant work rate exercise tests at 80% of the peak work rate will be carried out on two consecutive days with and without HFNT. The primary outcome will be the difference in endurance time between the two conditions. Secondary outcomes will be the change in muscle oxygenation during exercise, dyspnoea and muscle fatigue, respiratory muscle strength after exercise, respiratory rate, cardiac frequency, transcutaneous CO2 pressure and pulsed O2 saturation. Nineteen patients will be included. Data will be analysed as intention to treat by a blinded statistician.Ethics and disseminationEthics approval has been obtained from the Ethics Committees Nord-Ouest III, Caen, France (N° ID RCB: 2016-A01325-46). The study will begin in April 2017 for a duration of 2 years. The results of the trial will be presented at national and international meetings and published in peer-reviewed journals.Trial registration numberNCT03058081.

Nasal high flow does not improve exercise tolerance in COPD patients recovering from acute exacerbation: A randomized crossover study

“…Although the number of patients included corresponded to the initial sample size estimation, the SD of the endurance time for the NHF condition was actually higher than the SD used in the calculation of the sample size. This reduced the power of the study and increased the risk of type‐2 errors.…”

“…The study protocol was published previously and is registered on http://clinicaltrials.gov (NCT03058081). The study was conducted according to the protocol.…”

“…No encouragement was given during the tests. More details regarding the experimental conditions (technicians, instructions to the participants and performance of the tests) can be found in the protocol and Appendix S1 in Supplementary Information …”

“…Further information regarding the outcomes can be found in the published protocol and Appendix S1 in Supplementary Information …”

Effect of high-flow nasal therapy during exercise training in COPD patients with chronic respiratory failure: study protocol for a randomised controlled trial

“…HFNT will be administered using the AIRVO™ 2 device (Fisher & Paykel, Auckland, New Zealand). This system generates humidified, reheated air (between 31 °C and 37 °C) up to 60 L/min FiO 2 by altering the O 2 supplementation within the system (0.21–1 FiO 2 ) [23]. The air will be administered with an open-circuit through Optiflow™ nasal cannula (Fisher & Paykel).…”