Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05539391

Effectiveness of an Optimization Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial

Led by University Hospital, Bordeaux · Updated on 2025-09-24

1500

Participants Needed

22

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate in adult patients who require emergency tracheal intubation due to vital distress the effect of a combined strategy designed to reduce complications related to intubation. The study assesses how using rocuronium as a paralytic agent, providing bag face-mask ventilation before intubation, and systematically applying the Gum Elastic Bougie (GEB) at the first intubation attempt may impact intubation-related morbidity. Previous studies showed individual benefits of these approaches, but their combined effect in emergencies has not been assessed. The trial compares two groups: one group receives a combination rapid sequence intubation (RSI) strategy using rocuronium, bag-mask ventilation between induction and laryngoscopy, and systematic GEB use to aid intubation. The other group follows current recommendations using succinylcholine for RSI, no routine bag-mask ventilation before intubation, and GEB use only if intubation fails under direct laryngoscopy. Emergency physicians perform intubations and record outcomes. Participants will be monitored closely during and after intubation. Data collection includes medical history, vital signs such as arterial pressure, oxygen saturation, and heart rate. Researchers will track severe intubation-related complications occurring within the first hour and assess intubation difficulty using various measures on the day of intubation. Outcomes like mortality and use of sedatives or vasopressors are recorded up to 28 days after inclusion. The overall study period extends until September 2026.

CONDITIONS

Brief Title

Optimisation Strategy for Emergency Tracheal Intubation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 years or older
  • Patient requires emergency tracheal intubation due to vital distress in an out-of-hospital setting
  • Includes patients with conditions such as trauma, difficulty breathing, coma, overdose, and shock
  • Patient assessed by emergency physician and eligible outside of cardiac arrest cases
Not Eligible

You will not qualify if you...

  • Contraindication to succinylcholine, rocuronium, or sugammadex
  • Contraindication to bag face mask ventilation before intubation, such as ongoing vomiting, blood in mouth or lungs
  • Not a member of a medical aid scheme
  • Under specific protection measures including pregnancy, nursing, judicial protection, guardianship, or deprivation of liberty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single emergency intubation event

Participants undergo emergency tracheal intubation using either the optimized rapid sequence intubation strategy combining rocuronium, bag-mask ventilation, and Gum Elastic Bougie (GEB), or standard emergency intubation recommendations.

1 visit occurring at the time of emergency intubation

Follow-up

Duration - 28 days

Participants are observed for intubation-related complications and outcomes immediately after intubation and during the subsequent 28 days.

1 post-intubation follow-up visit on Day 28

Trial Site Locations

Total: 22 locations

1

CHU d'Angers

Angers, France, 49933

Actively Recruiting

2

CH Carnelle Portes de l'Oise

Beaumont-sur-Oise, France, 95260

Actively Recruiting

3

AP-HP - Hôpital Avicenne

Bobigny, France, 93000

Actively Recruiting

4

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33000

Actively Recruiting

5

CH de Pontoise René Dubos

Cergy-Pontoise, France, 95303

Actively Recruiting

6

AP-HP - Hôpital Henri Mondor

Créteil, France, 94000

Actively Recruiting

7

CHU de Dijon

Dijon, France, 21000

Not Yet Recruiting

8

GH Eaubonne Montmorency Hôpital Simone VEIL

Eaubonne, France, 95600

Actively Recruiting

9

AP-HP - Hôpital Raymond Poincaré

Garches, France, 92380

Actively Recruiting

10

CHU de Grenoble - Hôpital Nord La Tronche

La Tronche, France, 38700

Actively Recruiting

11

CH de Versailles - Site André Mignot

Le Chesnay, France, 78157

Not Yet Recruiting

12

HCL - Hôpital Edouard Herriot

Lyon, France, 69003

Actively Recruiting

13

GH Sud Ile de France

Melun, France, 77000

Actively Recruiting

14

CHU de Montpellier Site Lapeyronie

Montpellier, France, 34000

Actively Recruiting

15

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, France, 44093

Actively Recruiting

16

AP-HP - Hôpital Lariboisière

Paris, France, 75013

Actively Recruiting

17

AP-HP - Hôpital Pitié-Salpétrière

Paris, France, 75013

Actively Recruiting

18

AP-HP - Hôpital Necker

Paris, France, 75730

Actively Recruiting

19

CHU Poitiers - Hôpital la Milétrie

Poitiers, France, 86021

Actively Recruiting

20

CHU de la Réunion - site Sud

Saint-Pierre, France, 97448

Actively Recruiting

21

GH Sélestat Obernai

Sélestat, France, 67 600

Not Yet Recruiting

22

CHU Toulouse - Hôpital Purpan

Toulouse, France, 31059

Actively Recruiting

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Research Team

X

Xavier COMBES, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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