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Clinical Trials/NCT01232153
NCT01232153WithdrawnNot Applicable

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

Hopital of Melun2 sites in 1 countryStarted: March 1, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
length of hypoxemia
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients needing chest tube intubation

Exclusion Criteria

  • •Cardiac arrest
  • •Pregnancy
  • •Incompetents

Outcomes

Primary Outcomes

length of hypoxemia

Time Frame: 5 minutes

SpO2 below 85%

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hopital of Melun
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sebastien Jochmans, MD

MD

Hopital of Melun

Study Sites (2)

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