Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon

Not Applicable

Withdrawn

• Conditions: Preoxygenation
• Interventions: Device: Non invasive ventilation

• Registration Number: NCT01232153
• Lead Sponsor: Hopital of Melun

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2017-03-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2022-01-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients needing chest tube intubation

Exclusion Criteria

• Cardiac arrest
• Children
• Pregnancy
• Incompetents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV preoxygenation	Non invasive ventilation	-

Primary Outcome Measures

Name	Time	Method
length of hypoxemia	5 minutes	SpO2 below 85%

Trial Locations

Locations (1)

SAMU 77; 🇫🇷 Melun, France