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
  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
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: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sebastien Jochmans, MD, MD, Hopital of Melun
ClinicalTrials.gov Identifier: NCT01232153     History of Changes
Other Study ID Numbers: PREOXY
Study First Received: October 29, 2010
Last Updated: September 24, 2013
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 July 24, 2014