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NCT Number: NCT07791992

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

Why the study stopped: Le projet n'a pas obtenu l'autorisation réglementaire.
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Key information

Conditions

Hypercapnia Asthma Exacerbation COPD Exacerbation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Vibrating membrane nebulizer and high-intensity nasal oxygen

Device

Vibrating membrane nebulizer and high-intensity nasal oxygen

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

Primary outcomes

  1. 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%

Secondary outcomes

  1. FiO₂

    Time frame: at the end of care

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

  2. flow rate

    Time frame: at the end of care

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

  3. Likert scale

    Time frame: up to 30 minutes

    Likert scale on the ease of use of the device

  4. Causes of failure

    Time frame: up to 30 minutes

    For the "after" group

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: O2NAB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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