Impact of the Bougie on the Prehospital Setting Intubation Quality.

NCT05173220 | Unknown

• 1 other identifier: CHUBX-URG-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal intubation in an out-of-hospital setting is a frequent and potentially difficult procedure. The risk of adverse events increases dramatically with the number of attempts. The failure rate of the first intubation attempt ranges from 5 to 32% and the risk factors are unclear. In recent study, the prevalence of a failed first intubation attempt was 31.4% \[95% CI = 30.2-32.6\] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt. Some of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department and a prospective, observational, pre-post study design showed that systematic use of a bougie during the first intubation attempt improved the success rate. Our objective is to measure the impact of a modification of our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.

Conditions

Tracheal Intubation Morbidity; Prehospital Emergency

Keywords

difficult intubation; prehospital emergency; risk factors

Outcome Measures

Primary Outcomes (1)

• Failure of the first intubation attempt

  Yes/No

  1 hour

Secondary Outcomes (22)

• Number of prior intubations done by operator ≤ 50

  1 hour

• Operator position during intubation

  1 hour

• Gender

  1 hour

• Age

  1 hour

• Body mass index

  1 hour

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with life-threatening distress requiring emergency intubation.

You may qualify if:

• all patients intubated by Emergency Medical System (EMS) team

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Bruno Simonnet: collaborator

Study Sites (1)

CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU

Bordeaux, 33000, France

RECRUITING

Study Officials

• MICHEL GALINSKI, M.D, Ph.D

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• BRUNO SIMONNET, M.D

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MICHEL GALINSKI, M.D, Ph.D

CONTACT

+33678549415; michel.galinski@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 29, 2021
• Study Start: May 20, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

FR (1)