HypercapniaO2NABNCT07791992
Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After Study
An observational study of Hypercapnia and Asthma Exacerbation, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The aim of this observational before/after study is to determine how to optimally administer oxygen to patients experiencing an asthma or COPD exacerbation in emergency medical services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnia, Asthma Exacerbation, COPD Exacerbation
- What is being tested?
- Vibrating membrane nebulizer and high-intensity nasal oxygen and nebulizer mask and oxygen therapy of 6 to 9 liters per minute
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Observational
- 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
Study population: Patients treated by the Corbeil-Essonnes SMUR (mobile emergency and resuscitation service) for acute exacerbation of COPD or asthma
Who may be able to join
- ≥ 18 years of age
- Exacerbation of asthma or COPD requiring nebulization
- Free and informed consent
Who cannot join
- Clinical signs of hypercapnia
- Non French speaker
- Contraindications to high-flow nasal oxygen: haemodynamic instability, Glasgow < 12, cardiorespiratory arrest, lack of airway protection, cardiogenic pulmonary oedema
- Indication for orotracheal intubation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this observational before/after study is to determine how to optimally administer oxygen to patients experiencing an asthma or COPD exacerbation in emergency medical services.
The aim will be to determine which method will achieve the target oxygen saturation objectives: > 95% in asthma exacerbations and between 88% and 92% (or > 92% in ambient air or with FiO2 21%) in COPD exacerbations.
The study will compare a group "before" receiving standard care with a nebulizer mask to a group "after" using a combination of a vibrating membrane nebulizer and high-flow nasal oxygen.
Read the detailed description
The "after" group will systematically receive both devices: vibrating membrane nebulizer and high-flow nasal oxygen.
In both groups, the choice of nebulized therapies will be left to the clinician's discretion.
- Conditions
- Hypercapnia, Asthma Exacerbation, COPD Exacerbation
- Being tested
- Vibrating membrane nebulizer and high-intensity nasal oxygen, nebulizer mask and oxygen therapy of 6 to 9 liters per minute
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating membrane nebulizer and high-intensity nasal oxygenDevice
Vibrating membrane nebulizer and high-intensity nasal oxygen
nebulizer mask and oxygen therapy of 6 to 9 liters per minuteDevice
nebulizer mask and oxygen therapy of 6 to 9 liters per minute
| Study group | Role | What they receive |
|---|---|---|
| Before | Treatment of exacerbation with nebulizer mask and oxygen therapy of 6 to 9 liters per minute Receives: Device: nebulizer mask and oxygen therapy of 6 to 9 liters per minute | |
| After | Treatment of the exacerbation by combining a vibrating membrane nebulizer and high-flow nasal oxygen, set with an FiO₂ between 21 and 100% and an O₂ flow rate between 30 and 70 liters per minute Receives: Device: Vibrating membrane nebulizer and high-intensity nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of saturation targets
- Asthma: SpO₂ at 15 min > 95%
- COPD: SpO₂ at 15 min 88-92% or SpO₂ > 92% in ambient air or with FiO₂ 21%
Measured: at 15 minutes
Secondary outcomes (4)
FiO₂
Successful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices
Measured: at the end of care
flow rate
Successful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices
Measured: at the end of care
Likert scale
Likert scale on the ease of use of the device
Measured: up to 30 minutes
Causes of failure
For the "after" group
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: Le projet n'a pas obtenu l'autorisation réglementaire.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791992
- Sponsor's protocol ID
- 2026-A00725-46
- Acronym
- O2NAB
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After Study
- ClinicalTrials.gov ID
- NCT07791992
- Acronym / sponsor ID
- O2NAB / 2026-A00725-46
- Conditions
- Hypercapnia, Asthma Exacerbation, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Le projet n'a pas obtenu l'autorisation réglementaire.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
The aim of this observational before/after study is to determine how to optimally administer oxygen to patients experiencing an asthma or COPD exacerbation in emergency medical services.
The aim will be to determine which method will achieve the target oxygen saturation objectives: > 95% in asthma exacerbations and between 88% and 92% (or > 92% in ambient air or with FiO2 21%) in COPD exacerbations.
The study will compare a group "before" receiving standard care with a nebulizer mask to a group "after" using a combination of a vibrating membrane nebulizer and high-flow nasal oxygen.
Detailed description
The "after" group will systematically receive both devices: vibrating membrane nebulizer and high-flow nasal oxygen.
In both groups, the choice of nebulized therapies will be left to the clinician's discretion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | Device: nebulizer mask and oxygen therapy of 6 to 9 liters per minuteTreatment of exacerbation with nebulizer mask and oxygen therapy of 6 to 9 liters per minute |
| After | – | Device: Vibrating membrane nebulizer and high-intensity nasal oxygenTreatment of the exacerbation by combining a vibrating membrane nebulizer and high-flow nasal oxygen, set with an FiO₂ between 21 and 100% and an O₂ flow rate between 30 and 70 liters per minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by the Corbeil-Essonnes SMUR (mobile emergency and resuscitation service) for acute exacerbation of COPD or asthma
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Exacerbation of asthma or COPD requiring nebulization
- Free and informed consent
Key exclusion criteria (4 listed)
- Clinical signs of hypercapnia
- Non French speaker
- Contraindications to high-flow nasal oxygen: haemodynamic instability, Glasgow < 12, cardiorespiratory arrest, lack of airway protection, cardiogenic pulmonary oedema
- Indication for orotracheal intubation
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 |
|---|---|---|
| Vibrating membrane nebulizer and high-intensity nasal oxygenVibrating membrane nebulizer and high-intensity nasal oxygen | Device | After |
| nebulizer mask and oxygen therapy of 6 to 9 liters per minutenebulizer mask and oxygen therapy of 6 to 9 liters per minute | Device | Before |
Primary outcome
Achievement of saturation targets
Time frame: at 15 minutes
* Asthma: SpO₂ at 15 min > 95% * COPD: SpO₂ at 15 min 88-92% or SpO₂ > 92% in ambient air or with FiO₂ 21%
4 secondary outcomes
FiO₂
Time frame: at the end of care
flow rate
Time frame: at the end of care
Likert scale
Time frame: up to 30 minutes
Causes of failure
Time frame: up to 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercapnia
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
OSA COPD Overlap Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercapnia and Asthma Exacerbation, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Aug 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Achievement of saturation targets (time frame: at 15 minutes). 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 28 Aug 2026.