This trial is active, not recruiting.

Condition preoxygenation
Treatment non invasive ventilation
Phase phase 4
Sponsor Hopital of Melun
Collaborator Service d'Aide Médicale Urgente de Seine et Marne
Start date September 2015
End date January 2017
Trial size 230 participants
Trial identifier NCT01232153, PREOXY


Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
non invasive ventilation
Non invasive ventilation
(No Intervention)

Primary Outcomes

length of hypoxemia
time frame: 5 minutes

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients needing chest tube intubation Exclusion Criteria: - Cardiac arrest - Children - Pregnancy - Incompetents

Additional Information

Official title Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service
Description This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hopital of Melun.