High-Flow in Hypercapnic Stable COPD Patients (HIGH-FLOW)

May 17, 2022 updated by: University Hospital, Grenoble

Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study

Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous and systemic condition.

In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term home management.

A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key target for controlling nocturnal and diurnal hypoventilation and improving prognosis.

COPD is the clinical scenario during which a good NIV adherence is difficult to achieve. Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence to NIV.

During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation (NIV) treatment following French national recommendations and exhibiting a NIV compliance of (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will be randomized via a secure electronic website to either continue with their current NIV treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment adherence.

The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective patients centered outcomes, physical activity and nocturnal adherence to treatment.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Grenoble Alpes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for initiated at least 3 months prior the inclusion.
  • Compliance with NIV (less than 5 hours and more than 1 hour) per night on average during the last 3 months prior to inclusion.
  • Naïve to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months prior to inclusion.
  • Able to understand, follow objectives and methods of protocol in French language.
  • Patient affiliated to social security insurance or beneficiary of social health insurance.
  • Willing and able to give written Informed Consent and to comply with the requirements of the study protocol.

Exclusion Criteria:

  • Significant uncontrolled cardiac disease (investigator judgment), and/or Left Ventricular Ejection Fraction (LVEF) < 45%.
  • Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.
  • Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF, or, at the discretion of investigator, any other contraindication for using the NHF.
  • Patients who are unable or unwilling to give informed consent.
  • Participating in another research study.
  • Patient protected by the Law, under guardianship or curators.
  • Pregnancy and nursing mothers
  • Patient not covered by a health insurance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non Invasive Ventilation device group
The patients in the NIV arm will receive treatment as in their usual care with an additional educational session of one hour for improving compliance.
Device: Non Invasive Ventilation
Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.
Other: Education session
Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.
Experimental: Nasal High Flow (MyAirvo) device group
The patients in the NHF arm will receive NHF treatment and two hours training adaptation session will be conducted in the hospital.
Device: Nasal High Flow installation

Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2.

Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface

Other Names:
  • MyAirvo Device
Other: Training session
The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Differences in mean overnight transcutaneous PtCO2 measurement
between night at day 1 (baseline) and night at day 90 (3 months after)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Maximum PtCO2
between night at day 1 (baseline) and night at day 90 (3 months after)
Treatment adherence
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter & daily average of usage (screen display)
between night at day 1 (baseline) and night at day 90 (3 months after)
Daytime blood gas values in ambient air
Time Frame: between day 0 (inclusion) and day 97 (end of the study)
PaCO2 & PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group
between day 0 (inclusion) and day 97 (end of the study)
Other nocturnal parameter
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
Overnight Sp02 will be evaluated by nocturnal oximetry at home in order to determine: mean nocturnal SaO2, nadir nocturnal SaO2, cumulative time spent below 90% of SaO2 (CT<90%), Oxygen Desaturation Index.
between night at day 1 (baseline) and night at day 90 (3 months after)
Physical activity
Time Frame: for 7 days from the day 1 and for 7 days from the day 90
An actimetry will allow evaluating physical activity (number of steps)
for 7 days from the day 1 and for 7 days from the day 90
Sleep activity
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
An actimetry will allow evaluating total sleep time in minutes
between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
An actimetry will allow evaluating sleep onset latency in minutes
between night at day 1 (baseline) and night at day 90 (3 months after)
Sleep activity
Time Frame: between night at day 1 (baseline) and night at day 90 (3 months after)
An actimetry will allow evaluating sleep efficiency
between night at day 1 (baseline) and night at day 90 (3 months after)
Pulmonary function tests
Time Frame: between day 0 and day 97
Pulmonary function will be evaluated by routine patient care spirometry and will measure Vital capacity (VC) in liters
between day 0 and day 97
Pulmonary function tests
Time Frame: between day 0 and day 97
Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced vital capacity (FVC) in liters
between day 0 and day 97
Pulmonary function tests
Time Frame: between day 0 and day 97
Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters
between day 0 and day 97
Health related quality of life
Time Frame: between day 0 and day 97
Subjective functioning and quality of life will be measured by self-reporting questionnaire EQ-5D-5L
between day 0 and day 97
Health related quality of life
Time Frame: between day 0 and day 97
Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ
between day 0 and day 97
Cardiovasculary function
Time Frame: between day 0 and day 97
Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure
between day 0 and day 97
Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment
Time Frame: between day 0 and day 97
All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse
between day 0 and day 97

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Icadom
Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Jean-Louis Pépin, MD PhD, Laboratoire EFCR, CHU de Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

December 16, 2021

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38R19.250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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