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Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis

NCT06114667 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-07-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.

Conditions

  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease
  • Hypercapnic Acidosis
  • Respiratory Failure With Hypercapnia

Interventions

DEVICE

Ventilatory support via nasal high flow

Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

DEVICE

Ventilatory support via NIV

Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Mustapha Sebbane, MD, PhD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-11-01
Completion
2028-11-01

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 NCT06114667 on ClinicalTrials.gov