Pulmonary Disease, Chronic ObstructiveOxyCODNCT03488628
High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease.
A study testing Noninvasive ventilation and High-Flow Nasal Oxygen therapy in people with Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Noninvasive ventilation and High-Flow Nasal Oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2018to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Noninvasive ventilation, High-Flow Nasal Oxygen therapy
- Keywords
- respiratory failure, oxygen therapy, Noninvasive ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilationOther
Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
High-Flow Nasal Oxygen therapyOther
High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation | Active comparator | Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy Receives: Other: Noninvasive ventilation |
| High-Flow Nasal Oxygen therapy | Experimental | High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula. Receives: Other: High-Flow Nasal Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24 hours
Secondary outcomes (8)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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])
Measured: 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
Measured: 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
Measured: 24 hours
Severe Adverse events
Severe Adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start27 Jun 2018
- Primary completion3 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh Nay, MD, Principal investigator, Centre Hospitalier Régional d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488628
- Sponsor's protocol ID
- CHRO-2017-16
- Other IDs
- ID RCB: 2017-A03535-48
- Acronym
- OxyCOD
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2018
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.
- ClinicalTrials.gov ID
- NCT03488628
- Acronym / sponsor ID
- OxyCOD / CHRO-2017-16
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- respiratory failure, oxygen therapy, Noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation | Active comparator | Other: Noninvasive ventilationNoninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy |
| High-Flow Nasal Oxygen therapy | Experimental | Other: High-Flow Nasal Oxygen therapyHigh-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Age below 18
- Pregnancy
- Known sleep apnea syndrome
- Patent treated by noninvasive ventilation at home
- Not affiliated to French scial security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive ventilationNoninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours | Other | Noninvasive ventilation |
| High-Flow Nasal Oxygen therapyHigh-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 |
Primary outcome
Arterial pH at 24 hours
Time frame: 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
Time frame: 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)
8 secondary outcomes
Cumulative incidence of tracheal intubation
Time frame: 28 days
Time course of arterial pH
Time frame: 24 hours
Arterial partial pressure in carbon dioxide (PaCO2)
Time frame: 24 hours
Time course of arterial oxygen saturation (SaO2)
Time frame: 24 hours
Self-reported dyspnea score
Time frame: 24 hours
Perceived nursing workload
Time frame: 24 hours
Proportion of patients who will need Noninvasive ventilation in the High-Flow Nasal Oxygen group from randomisation through the 24th hour
Time frame: 24 hours
Severe Adverse events
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Anh Nay, MD principal investigator
Centre Hospitalier Régional d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation and High-Flow Nasal Oxygen therapy in people with Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial pH at 24 hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.