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High-Flow in Hypercapnic Stable COPD Patients

NCT04281316 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-05-24

No results posted yet for this study

Summary

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.

Conditions

  • Adherence, Treatment

Interventions

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

DEVICE

Non Invasive Ventilation

Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.

OTHER

Training session

The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital

OTHER

Education session

Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Louis Pépin, MD PhD · Laboratoire EFCR, CHU de Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-12-16
Completion
2021-12-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281316 on ClinicalTrials.gov