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

This study is ongoing, but not recruiting participants.
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: March 26, 2017
Last verified: March 2017
  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
Preoxygenation
Device: Non invasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    SpO2 below 85%


Estimated Enrollment: 230
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: July 1, 2019
Estimated Primary Completion Date: January 1, 2018 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Melun, France, 77000
Sponsors and Collaborators
Hopital of Melun
Service d'Aide Médicale Urgente de Seine et Marne
  More Information

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: March 26, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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 April 28, 2017