Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

Phase 3

Completed

• Conditions: Respiratory Distress; Coma; Major Trauma; Shock

• Registration Number: NCT02000674
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief Summary

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

Detailed Description

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the conditions of intubation assessed by the Copenhagen score, the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-11-27
• Study Start: 2013-12
• Study First Posted: 2013-12-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1321

Inclusion Criteria

• All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context

Exclusion Criteria

• Patients in cardiac arrest;
• Patients under-18s;
• Patients under guardianship ;
• Pregnancy known;
• Patients with cons to one of the following three drugs: rocuronium, succinylcholine, sugammadex;
• Patients not affiliated to a social security scheme (beneficiary or legal).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First-pass intubation success rate	between 1 hour to 3 hours after inclusion	Measured by the proportion of successful intubation in the first laryngoscopy.

Secondary Outcome Measures

Name	Time	Method
Incidence of difficult intubation	between 1 hour to 3 hours after inclusion	measured by the Intubation Difficulty Scale
Intubation conditions assessment	between 1 hour to 3 hours after inclusion	using the Copenhagen score
Need for alternate airway devices	between 1 hour to 3 hours after inclusion
early intubation-related complications	between 1 hour to 3 hours after inclusion	complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest

Trial Locations

Locations (17)

CHU Necker; 🇫🇷 Paris, France

CHU de La Réunion; 🇫🇷 Saint Denis, La Réunion, France

CHU de la Réunion; 🇫🇷 Saint Pierre, La Réunion, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU Avicenne; 🇫🇷 Bobigny, France

CH René Dubos; 🇫🇷 Pontoise, France

CHU de Nîmes; 🇫🇷 Nîmes, France

CHU Lariboisière; 🇫🇷 Paris, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CH Gonesse; 🇫🇷 Gonesse, France

CHU Raymond Poincaré; 🇫🇷 Garches, France

CHRU de Lille; 🇫🇷 Lille, France

CHU Hôtel-Dieu; 🇫🇷 Paris, France

CH Marc Jacquet; 🇫🇷 Melun, France

CHU Pitié-Salpêtrière; 🇫🇷 Paris, France

CH Annecy; 🇫🇷 Pringy, France

CHU Toulouse - Hôpital PURPAN; 🇫🇷 Toulouse, France