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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07791992
Acronym
O2NAB
Enrollment
0
Registered
2026-08-28
Start date
2026-10-01
Completion date
2027-10-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Exacerbation, COPD Exacerbation, Hypercapnia

Brief 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.

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.

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

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Achievement of saturation targetsat 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

MeasureTime frameDescription
FiO₂at the end of careSuccessful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices
flow rateat the end of careSuccessful implementation of the vibrating membrane nebulizer and high-flow nasal oxygen devices
Likert scaleup to 30 minutesLikert scale on the ease of use of the device
Causes of failureup to 30 minutesFor the "after" group

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026