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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Noninvasive ventilation
High-Flow Nasal Oxygen therapy
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring respiratory failure, oxygen therapy, Noninvasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'OrléansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Noninvasive ventilation

High-Flow Nasal Oxygen therapy

Arm Description

Noninvasive ventilation delivered through a face mask, in alternance with standard 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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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
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)
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)
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)
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])
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
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
Severe Adverse events
Severe Adverse events

Full Information

First Posted
March 26, 2018
Last Updated
December 27, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03488628
Brief Title
High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease.
Acronym
OxyCOD
Official Title
High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
July 27, 2025 (Anticipated)
Study Completion Date
July 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
respiratory failure, oxygen therapy, Noninvasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive ventilation
Arm Type
Active Comparator
Arm Description
Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy
Arm Title
High-Flow Nasal Oxygen therapy
Arm Type
Experimental
Arm Description
High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher & Paykel Healthcare,New Zealand) through nasal canula.
Intervention Type
Other
Intervention Name(s)
Noninvasive ventilation
Intervention Description
Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
Intervention Type
Other
Intervention Name(s)
High-Flow Nasal Oxygen therapy
Intervention Description
High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher & Paykel Healthcare,New Zealand) through nasal canula.
Primary Outcome Measure Information:
Title
Arterial pH at 24 hours
Description
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)
Time Frame
24 hours
Title
PaO2/FiO2 ratio at 24 hours
Description
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)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Cumulative incidence of tracheal intubation
Description
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
Time Frame
28 days
Title
Time course of arterial pH
Description
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)
Time Frame
24 hours
Title
Arterial partial pressure in carbon dioxide (PaCO2)
Description
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)
Time Frame
24 hours
Title
Time course of arterial oxygen saturation (SaO2)
Description
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)
Time Frame
24 hours
Title
Self-reported dyspnea score
Description
Patients will grade their dyspnea every 6 hours on a 5-point numeric scale (ranging from -2 [marked worsening] to +2 [frank improvement])
Time Frame
24 hours
Title
Perceived nursing workload
Description
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
Time Frame
24 hours
Title
Proportion of patients who will need Noninvasive ventilation in the High-Flow Nasal Oxygen group from randomisation through the 24th hour
Description
Need of Noninvasive ventilation in the High-Flow Nasal Oxygen group
Time Frame
24 hours
Title
Severe Adverse events
Description
Severe Adverse events
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Despujols
Phone
33 2 38 74 40 71
Email
aurelie.despujols@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Boulain, MD
Phone
33 2 38 51 44 46
Email
thierry.boulain@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Anh Nay, MD
Organizational Affiliation
Centre Hospitalier Régional d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai-Anh NAY, DR
Email
mai-anh.nay@chr-orleans.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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