Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon (PREOXY)

This study is ongoing, but not recruiting participants.
Service d'Aide Médicale Urgente de Seine et Marne
Information provided by (Responsible Party):
Sebastien Jochmans, MD, Hopital of Melun Identifier:
First received: October 29, 2010
Last updated: September 22, 2015
Last verified: September 2015

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.

Condition Intervention Phase
Device: Non invasive ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

Further study details as provided by Hopital of Melun:

Primary Outcome Measures:
  • length of hypoxemia [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: September 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NIV preoxygenation Device: Non invasive ventilation
Non invasive ventilation
No Intervention: Classical preoxygenation

Detailed Description:

This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients needing chest tube intubation

Exclusion Criteria:

  • Cardiac arrest
  • Children
  • Pregnancy
  • Incompetents
  Contacts and Locations
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Please refer to this study by its identifier: NCT01232153

Melun, France, 77000
Sponsors and Collaborators
Hopital of Melun
Service d'Aide Médicale Urgente de Seine et Marne
  More Information

No publications provided

Responsible Party: Sebastien Jochmans, MD, MD, Hopital of Melun Identifier: NCT01232153     History of Changes
Other Study ID Numbers: PREOXY
Study First Received: October 29, 2010
Last Updated: September 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Hopital of Melun:
chest tube
patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services processed this record on October 09, 2015