Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon

Preoxygenation Clinical Trial

— PREOXY  

Official title:

Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01232153
• Other study ID #: PREOXY
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2020
• Source: Hopital of Melun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients needing chest tube intubation

Exclusion Criteria:

• Cardiac arrest

• Children

• Pregnancy

• Incompetents

Related Conditions & MeSH terms

• Preoxygenation

Intervention

Device:
• Non invasive ventilation
Non invasive ventilation

Locations

Country	Name	City	State
France	SAMU 77	Melun

Sponsors (2)

Lead Sponsor	Collaborator
Hopital of Melun	Service d'Aide Médicale Urgente de Seine et Marne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hypoxemia	SpO2 below 85%	5 minutes