Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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