Nasal High-Flow in COPD (High-TeC)

Marieke Duiverman

Status: Enrolling

Conditions: COPD Exacerbation

Treatments: Other: Standard care; Device: Nasal High Flow Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03564236

201800398

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

Standard care is provided according to our local COPD exacerbation protocol. All patients are treated with: * oral prednisolone 40 mg/day for 5 days; * antibiotics prescribed according to the following criteria: fever (body temperature \> 38.5 degrees Celsius), elevated C-reactive protein (CRP) \>50, change in sputum colour, and/or according to the physician's decision of severe illness, and/or in all patients with a FEV1 \<30% of predicted; * high dose inhaled corticosteroids, beta-agonists and or anticholinergics. * Oxygen will be prescribed in all patients through a standard low flow system in order to maintain an adequate arterial oxygen saturation (Sa,O2) Patients will be discharged with regular low flow oxygen once they fulfil the criteria for long-term oxygen therapy.

Treatment:

Other: Standard care

Nasal High Flow Therapy

Experimental group

Description:

In addition to the standard care described above, patients in the intervention group will be treated with: * nHFT, set at 30-50 L/min flow with oxygen to achieve an adequate oxygen saturation. nHFT is prescribed for at least 6 hours, but patients are stimulated to use the device as much as possible during the hospital stay. * During periods without HFT through a standard low flow system, to maintain an adequate arterial oxygen saturation (Sa,O2) (between 90-92% if patients are concomitantly hypercapnic, and between 90-95% if patients are normocapnic). Flow rates are titrated accordingly. * After discharge patients in the nHFT arm will continue the prescribed therapy at home for 90 subsequent days.

Treatment:

Device: Nasal High Flow Therapy