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

NCT07791992 | Withdrawn

• 1 other identifier: 2026-A00725-46
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnia; COPD Exacerbation; Asthma Exacerbation

Outcome Measures

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%

  at 15 minutes

Secondary Outcomes (4)

• FiO₂

  at the end of care

• flow rate

  at the end of care

• Likert scale

  up to 30 minutes

• Causes of failure

  up to 30 minutes

Study Arms (2)

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

Vibrating membrane nebulizer and high-intensity nasal oxygen DEVICE

Vibrating membrane nebulizer and high-intensity nasal oxygen

After

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

Before

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)