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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Hopital of Melun
Sponsor:
Collaborator:
Service d'Aide Médicale Urgente de Seine et Marne
Information provided by (Responsible Party):
Sebastien Jochmans, MD, Hopital of Melun
ClinicalTrials.gov Identifier:
NCT01232153
First received: October 29, 2010
Last updated: September 24, 2013
Last verified: September 2013

October 29, 2010
September 24, 2013
November 2013
September 2014   (final data collection date for primary outcome measure)
length of hypoxemia [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01232153 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Preoxygenation
Device: Non invasive ventilation
Non invasive ventilation
  • Active Comparator: NIV preoxygenation
    Intervention: Device: Non invasive ventilation
  • No Intervention: Classical preoxygenation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
230
November 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients needing chest tube intubation

Exclusion Criteria:

  • Cardiac arrest
  • Children
  • Pregnancy
  • Incompetents
Both
18 Years and older
No
France
 
NCT01232153
PREOXY
Yes
Sebastien Jochmans, MD, Hopital of Melun
Hopital of Melun
Service d'Aide Médicale Urgente de Seine et Marne
Not Provided
Hopital of Melun
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP