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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Hopital of Melun.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Service d'Aide Médicale Urgente de Seine et Marne
Information provided by:
Hopital of Melun
ClinicalTrials.gov Identifier:
NCT01232153
First received: October 29, 2010
Last updated: August 4, 2011
Last verified: October 2010
History of Changes
  Purpose

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
Preoxygenation
 Device: Non invasive ventilation
Device: Classical preoxygenation
 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 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NIV preoxygenation Device: Non invasive ventilation
NIV
No Intervention: Classical preoxygenation Device: Classical preoxygenation
Classical preoxygenation

Detailed Description:

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

  Eligibility

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

Inclusion Criteria:

  • Patients needing chest tube intubation

Exclusion Criteria:

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

Locations
France
SAMU 77 Not yet recruiting
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: Sébastien JOCHMANS, MD, Hospital of Melun
ClinicalTrials.gov Identifier: NCT01232153     History of Changes
Other Study ID Numbers: PREOXY
Study First Received: October 29, 2010
Last Updated: August 4, 2011
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
preoxygenation
NIV
out-of-hospital
patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services

ClinicalTrials.gov processed this record on May 16, 2013