High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease.
NCT ID: NCT03488628
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
51 participants
INTERVENTIONAL
2018-06-27
2025-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Noninvasive ventilation
Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy
Noninvasive ventilation
Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Noninvasive ventilation
Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mai-Anh Nay, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Régional d'Orléans
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHR d'Orléans
Orléans, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ID RCB: 2017-A03535-48
Identifier Type: OTHER
Identifier Source: secondary_id
CHRO-2017-16
Identifier Type: -
Identifier Source: org_study_id