CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 171 enrolled
Drug / intervention
HFOdevice
Likely dose
Not stated in record
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Search/NCT03322787
NCT03322787N/ACompleted

Effect of Exercise Training Under High Flow Oxygen (HFO) Device on Endurance Tolerance in Patients With COPD and Chronic Respiratory Failure: a Randomized Controlled Study.

Istituti Clinici Scientifici Maugeri SpA·interventional·Posted Oct 26, 2017·Updated May 29, 2019

In Brief

A clinical study evaluating HFO for COPD. Completed, enrolled 171 participants across 1 site.

Detailed Summary

Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome. Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" . Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartNov 6, 2017
Primary CompletionDec 8, 2018
Study CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.7 years ago

Interventions

HFOdevice

Training will be done using the HFO device. Air-flow will set at the highest value tolerated by the patients, until a maximum value of 60 l/min permitted and FiO2 set during the run-in. The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.