Nasal High-Flow in COPD (High-TeC)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    136
  • sponsor
    Marieke Duiverman
Updated on 10 February 2022
antibiotic therapy
respiratory failure
pao2
respiratory symptoms
pulmonary disease
obstructive lung disease

Summary

Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations.

Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown.

Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT.

Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating.

Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included.

Intervention (if applicable): Patients will be randomised to standard care or nHFT ( 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care.

Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.

Description

The study will be a parallel group 2-arms non blinded multicentre 2-phase randomised controlled trial comparing the effect of nHFT on subjective recovery in COPD patients admitted to the hospital for a COPD exacerbation as compared to the standard care. First, we will define the optimal setting and gain more insight in insight in mechanisms why and how nHFT might work in a subpopulation, then continuing with inclusion in the randomized controlled trial including the 136 patients in total to prove efficacy in terms of patient-centered outcomes. To get more insight in mechanisms why and how nHFT might work we incorporate: a) neuromechanical investigations and analyses; and b) anatomical investigations, both in patients and in experimental models, the latter in order to minimise patient effort.

Details
Condition COPD Exacerbation
Treatment Standard Care, nasal high flow therapy
Clinical Study IdentifierNCT03564236
SponsorMarieke Duiverman
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients have to fulfil all of the following inclusion criteria
History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio <70), with a history of at least 10 pack years smoking
Being admitted to the hospital with a COPD exacerbation
Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) 8.0 kPa at room air), with pH > 7.34
At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
Written informed consent is obtained

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study
No lung function data available
The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
Inability to comply with the tests
The presence of another chronic lung disease (e.g. asthma, restrictive lung disease)
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