High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease. (OxyCOD)

High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.

High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.

The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Noninvasive ventilation; Other: High-Flow Nasal Oxygen therapy

Detailed Description

As soon as admission to the intensive care unit, eligible patients who gave consent will be randomized to either HFNO or Noninvasive ventilation therapy for at least the first 24 hours.

In the usual care group , Noninvasive ventilation will be applied in alternance with standard nasal oxygen therapy.

In the intervention group, HFNO with be applied continuously over the first 24 hours.

In both groups, an oxygen saturation, as assessed by finger pulse oximetry, of 88-92% will be targeted.

The primary objective will be two-fold: to compare between groups 1) Efficacy, assessed by the arterial pH at 24 hours, and 2) Safety, assessed by the ratio of the arterial partial pressure in oxygen (PaO2) over the inspired oxygen fraction (FiO2) at 24 hours.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orleans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18
• Known Chronic Obstructive Pulmonary disease (COPD)
• respiratory rate or presence of accessory respiratory muscles activity on physical exam
• moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg

Exclusion Criteria:

• Age below 18
• Pregnancy
• Known sleep apnea syndrome
• Patent treated by noninvasive ventilation at home
• Not affiliated to French scial security
• Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy
• Previous inclusion in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Noninvasive ventilation; Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy	Other: Noninvasive ventilation; Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
Experimental: High-Flow Nasal Oxygen therapy; High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher & Paykel Healthcare,New Zealand) through nasal canula.	Other: High-Flow Nasal Oxygen therapy; High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher & Paykel Healthcare,New Zealand) through nasal canula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pH at 24 hours	Arterial pH at 24 hours, the primary efficacy criteria, is planned to be jointly assessed and analysed with the primary safety criteria (PaO2/FiO2 ratio at 24 hours)	24 hours
PaO2/FiO2 ratio at 24 hours	PaO2/FiO2 ratio at 24 hours, the primary safety criteria, is planned to be jointly assessed and analysed with the primary efficacy criteria (arterial pH at 24 hours)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of tracheal intubation	Cumulative incidence of tracheal intubation from randomisation through Day 28, with discharge alive or death (without having been intubated) before day 28 handled as competing events	28 days
Time course of arterial pH	Arterial pH will be measured 5 times over the first 24 hours (before application of the randomized intervention, 1 hour after and then at H6, H12 and H24)	24 hours
Arterial partial pressure in carbon dioxide (PaCO2)	PaCO2 be measured 5 times over the first 24 hours (before application of the randomized intervention, 1 hour after and then at H6, H12 and H24)	24 hours
Time course of arterial oxygen saturation (SaO2)	SaO2 will be measured by oximetry on arterial blood samples, 5 times over the first 24 hours (before application of the randomized intervention, 1 hour after and then at H6, H12 and H24)	24 hours
Self-reported dyspnea score	Patients will grade their dyspnea every 6 hours on a 5-point numeric scale (ranging from -2 [marked worsening] to +2 [frank improvement])	24 hours
Perceived nursing workload	Nurses will rate perceived workload on a 100 mm-visual numeric scale (ranging from 0 [negligible workload] to 100 mm [the most demanding task ever experienced] every 4 hours	24 hours
Proportion of patients who will need Noninvasive ventilation in the High-Flow Nasal Oxygen group from randomisation through the 24th hour	Need of Noninvasive ventilation in the High-Flow Nasal Oxygen group	24 hours
Severe Adverse events	Severe Adverse events	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Mai-Anh Nay, MD, Centre Hospitalier Régional D'orléans

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): October 3, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: respiratory failure; Noninvasive ventilation; oxygen therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: CHRO-2017-16; ID RCB: 2017-A03535-48 (Other Identifier: French Ministry of Health)

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