PREOXY: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon
Sponsor
Hopital of Melun (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01232153
Collaborator
Service d'Aide Médicale Urgente de Seine et Marne (Other)
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Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Actual Study Start Date
:
Mar 1, 2017
Anticipated Primary Completion Date
:
Jan 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: NIV preoxygenation
|
Device: Non invasive ventilation
Non invasive ventilation
|
| No Intervention: Classical preoxygenation
|
Outcome Measures
Primary Outcome Measures
- length of hypoxemia [5 minutes]
SpO2 below 85%
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients needing chest tube intubation
Exclusion Criteria:
-
Cardiac arrest
-
Children
-
Pregnancy
-
Incompetents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SAMU 77 | Melun | France | 77000 |
Sponsors and Collaborators
- Hopital of Melun
- Service d'Aide Médicale Urgente de Seine et Marne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sebastien Jochmans, MD,
MD,
Hopital of Melun
ClinicalTrials.gov Identifier:
NCT01232153
Other Study ID Numbers:
- PREOXY
First Posted:
Nov 2, 2010
Last Update Posted:
Sep 2, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
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 Sebastien Jochmans, MD,
MD,
Hopital of Melun