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WithdrawnNCT07791992O2NABUpdated Aug 28, 2026

Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After Study

An observational study in Hypercapnia, Asthma Exacerbation and COPD Exacerbation, sponsored by Centre Hospitalier Sud Francilien. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Why this study was withdrawn
Le projet n'a pas obtenu l'autorisation réglementaire.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hypercapnia
  • Asthma Exacerbation
  • COPD Exacerbation

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03

In context

Hypercapnia

156 studies on the registry are indexed under Hypercapnia; 31 are open to participants now.

Browse Hypercapnia studies →

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated by the Corbeil-Essonnes SMUR (mobile emergency and resuscitation service) for acute exacerbation of COPD or asthma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 18 years of age
  • Exacerbation of asthma or requiring nebulization
  • Free and

Exclusion criteria

Exclusion Criteria:

  • Clinical signs of hypercapnia
  • Non French speaker
  • to high-flow nasal oxygen: haemodynamic instability, Glasgow \< 12, cardiorespiratory arrest, lack of airway protection, cardiogenic pulmonary oedema
  • Indication for orotracheal intubation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Before

    Treatment of exacerbation with nebulizer mask and oxygen therapy of 6 to 9 liters per minute

    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

    Device: Vibrating membrane nebulizer and high-intensity nasal oxygen

Interventions

  • DeviceVibrating membrane nebulizer and high-intensity nasal oxygen

    Vibrating membrane nebulizer and high-intensity nasal oxygen

  • Devicenebulizer mask and oxygen therapy of 6 to 9 liters per minute

    nebulizer mask and oxygen therapy of 6 to 9 liters per minute

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: at 15 minutes

Secondary outcomes

  1. FiO₂

    Successful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices

    Time frame: at the end of care

  2. flow rate

    Successful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices

    Time frame: at the end of care

  3. Likert scale

    Likert scale on the ease of use of the device

    Time frame: up to 30 minutes

  4. Causes of failure

    For the "after" group

    Time frame: up to 30 minutes

07

Study locations

1 site
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, 91100, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
Aug 28, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Oct 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791992
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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