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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232153
First Posted: November 2, 2010
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Service d'Aide Médicale Urgente de Seine et Marne
Information provided by (Responsible Party):
Sebastien Jochmans, MD, Hopital of Melun
October 29, 2010
November 2, 2010
March 28, 2017
March 1, 2017
January 1, 2018   (Final data collection date for primary outcome measure)
length of hypoxemia [ Time Frame: 5 minutes ]
SpO2 below 85%
length of hypoxemia [ Time Frame: 5 minutes ]
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
 
Active, not recruiting
230
July 1, 2019
January 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients needing chest tube intubation

Exclusion Criteria:

  • Cardiac arrest
  • Children
  • Pregnancy
  • Incompetents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01232153
PREOXY
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Sebastien Jochmans, MD, Hopital of Melun
Hopital of Melun
Service d'Aide Médicale Urgente de Seine et Marne
Not Provided
Hopital of Melun
March 2017

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