Dataset Information

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

ABSTRACT:

Background

The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded from most studies, are frequently unable to sustain a work-load sufficiently high to obtain the full benefit of PR on exercise tolerance. Recent studies involving heated and humidified high flow oxygen therapy (HFOT) showed positive effects on breathing pattern and ventilatory efficiency during effort. We thus plan to compare, in COPD patients with CRF undergoing a high-intensity exercise programme, the effect of using HFOT versus standard oxygen delivery via Venturi Mask (V-mask), at the same inspiratory oxygen fraction, on improving exercise endurance.

Methods/design

This is a multicentre randomised controlled trial that will involve 156 COPD inpatients with CRF recruited from seven PR hospitals. Patients will be randomised to one of two groups - V-mask versus HFOT. All patients will undergo the same high-intensity exercise programme using either of the oxygen delivery devices as per their group allocation. Training will consist of 20 sessions, over 1?month (5 sessions per week) within the hospitalisation period. Anthropometric and clinical data, including body mass index, diagnosis, spirometry and comorbidities (Cumulative Rating Scale) will be collected at baseline. At baseline and at the end of the exercise programme (primary assessment time) evaluation will include exercise tolerance (Constant Work Rate Exercise Test) (primary outcome), functional capacity (6-min walk test), maximal inspiratory pressure/maximal expiratory pressure, peripheral muscle strength (biceps and quadriceps) by manual dynamometer, respiratory exchanges (blood gases analysis), disability (Barthel Index and Barthel Dyspnoea Index), impact of disease (COPD Assessment test), and quality of life (Maugeri Respiratory Failure Scale-26). At the end of the training period, patient satisfaction will be evaluated.

Discussion

This study will add knowledge about the exercise response in advanced COPD with CRF and verify if an alternative tool, namely HFOT, can increase the benefit obtained from PR.

Trial registration

ClinicalTrials.gov ID NET03322787 Registered: 6 November 2017.

SUBMITTER: Vitacca M

PROVIDER: S-EPMC6556225 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Vitacca Michele M Pietta Irene I Lazzeri Marta M Paneroni Mara M

Trials 20190608 1

<h4>Background</h4>The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded from most studies, are frequently unable to sustain a work-load sufficiently high to obtain the full benefit of PR on exercise tolerance. Recent studies involving heated and humidified high flow oxygen therapy (HFOT) showed positive effects on breathing pattern and ventilat ...[more]

PMID: 31176375

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Project description:BackgroundPeople with very severe chronic obstructive pulmonary disease (COPD) using nocturnal non-invasive ventilation (NIV) for chronic hypercapnic respiratory failure (CHRF) experience reduced exercise capacity and severe dyspnoea during exercise training (ET). The use of NIV during ET can personalise training during pulmonary rehabilitation (PR) but whether high-intensity NIV (HI-NIV) during exercise is accepted and improves outcomes in these extremely physically limited patients is unknown. The aim of this trial was to determine if ET with HI-NIV during PR was more effective than without at improving exercise capacity and reducing dyspnoea during exercise.MethodsPatients with COPD, CHRF and nocturnal-NIV were randomised to supervised cycle-ET as part of PR with HI-NIV or without (control). Primary outcome was change in cycle endurance time (ΔCETtime), while secondary outcomes were dyspnoea at isotime during the cycle endurance test and during ET-sessions and for the HI-NIV group, post-trial preferred exercising method.ResultsTwenty-six participants (forced expiratory volume in 1 s 22±7%pred, PaCO251±7 mm Hg) completed the trial (HI-NIV: n=13, ET: IPAP 26±3/EPAP 6±1 cm H2O; control n=13). At completion of a 3 week ET-programme, no significant between-group differences in ΔCETtime were seen (HI-NIV-control: Δ105 s 95% CI (-92 to 302), p=0.608). Within-group ΔCETtime was significant (HI-NIV: +246 s 95% CI (61 to 432); control: +141 s 95% CI (60 to 222); all p<0.05). The number of responders (Δ>minimal important difference (MID)101 s: n=53.8%) was the same in both groups for absolute ΔCETtime and 69.2% of control and 76.9% of the HI-NIV group had a %change>MID33%.Compared with control, the HI-NIV group reported less isotime dyspnoea (Δ-2.0 pts. 95% CI (-3.2 to -0.8), p=0.005) and during ET (Δ-3.2 pts. 95% CI (-4.6 to -1.9), p<0.001). Most of the HI-NIV group (n=12/13) preferred exercising with NIV.ConclusionIn this small group of patients with very severe COPD requiring nocturnal NIV, participation in an ET-programme during PR significantly improved exercise capacity irrespective of HI-NIV use. Reported dyspnoea was in favour of HI-NIV.Trial registration numberNCT03803358.

Project description:IntroductionAcute hypoxaemic respiratory failure (AHRF) in children is the most frequent reason for non-elective hospital admission. During the initial phase, AHRF is a clinical syndrome defined for the purpose of this study by an oxygen requirement and caused by pneumonia, lower respiratory tract infections, asthma or bronchiolitis. Up to 20% of these children with AHRF can rapidly deteriorate requiring non-invasive or invasive ventilation. Nasal high-flow (NHF) therapy has been used by clinicians for oxygen therapy outside intensive care settings to prevent escalation of care. A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy. No similar data is available in the older children presenting with AHRF. In this study we aim to investigate in children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with standard-oxygen therapy reduces hospital length of stay and if this is cost-effective compared with standard treatment.Methods and analysisThe study design is an open-labelled randomised multicentre trial comparing early NHF and standard-oxygen therapy and will be stratified by sites and into obstructive and non-obstructive groups. Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments will be randomly allocated to NHF or standard-oxygen therapy once the eligibility criteria have been met (oxygen requirement with transcutaneous saturation <92%/90% (dependant on hospital standard threshold), diagnosis of AHRF, admission to hospital and tachypnoea ?35 breaths/min). Children in the standard-oxygen group can receive rescue NHF therapy if escalation is required. The primary outcome is hospital length of stay. Secondary outcomes will include length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs. Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationEthics approval has been obtained in Australia (HREC/15/QRCH/159) and New Zealand (HDEC 17/NTA/135). The trial commenced recruitment in December 2017. The study findings will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Authorship of all publications will be decided by mutual consensus of the research team.Trial registration numberACTRN12618000210279.

Project description:BackgroundNoninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis.MethodsWe will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO2 ≥ 55 mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3-5 cmH2O with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality. Based on an α error of 5% and a β error of 80%, with a standard deviation for PaCO2 equal to 15 mmHg and a noninferiority limit of 10 mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group).DiscussionHFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis.Trial registrationClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.

Project description:INTRODUCTION:High-flow nasal oxygen (HFNO) use in adults hospitalised with acute respiratory failure (ARF) is increasing. However, evidence to support widespread use of HFNO compared with non-invasive ventilation (NIV) and conventional oxygen therapy (COT) is unclear. This protocol describes the methods for a systematic evidence review regarding the comparative effectiveness and harms of HFNO compared with NIV or COT for the management of ARF in hospitalised adult patients. METHODS AND ANALYSIS:We will search MEDLINE, Embase, CINAHL and Cochrane Library for randomised-controlled trials (RCTs) of adult patients hospitalised with ARF or who developed ARF while hospitalised. ARF will be defined as SpO2 <90%, PaO2:FiO2 ratio ?300, PaO2 ?60?mm Hg, or PaCO2 ?45?mm Hg. The intervention is HFNO (humidified oxygen, flow rate ?20?L/min) compared separately to NIV or COT. The critical outcomes are: all-cause mortality, hospital-acquired pneumonia, intubation/reintubation (days of intubation), intensive care unit admission/transfers, patient comfort and hospital length of stay. The important outcomes are: delirium, 30-day hospital readmissions, barotrauma, compromised nutrition (enteral or parenteral nutrition), gastric dysfunction, functional independence at discharge and skin breakdown or pressure ulcers. We will calculate risk ratios and Peto ORs (for rare events) and corresponding 95% CIs for categorical outcomes. Mean and standardised mean difference will be calculated for continuous outcomes. Where possible and appropriate, meta-analysis will be performed for each outcome. CONCLUSION:This systematic review will provide a comprehensive evaluation of the evidence regarding the comparative effectiveness and harms of HFNO compared with NIV or COT for the management of ARF in hospitalised adult patients to inform clinical practice and to identify research gaps in the management of ARF in hospitalised adults. The results will inform the work of the American College of Physicians-Clinical Guidelines Committee in their development of a clinical guideline related to use of HFNO in adult patients with ARF. ETHICS AND DISSEMINATION:No ethical approval will be needed because we will be using data from previously published studies in which informed consent was obtained by the primary investigators. We will publish our results in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019146691.

Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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