Clinical trial NCT02000674: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation
Official title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coma
Major Trauma
Respiratory Distress
Shock
Keywords: tracheal intubation
pre hospital emergency
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Unité de Soutien Méthodologique (CHU de La Réunion)
name: SAMU de Paris, Hôpital Necker - Enfants Malades
First posted: 2013-12-04
Enrollment: 1321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: First-pass intubation success rate
timeFrame: between 1 hour to 3 hours after inclusion
Secondary outcomes:
measure: Incidence of difficult intubation
timeFrame: between 1 hour to 3 hours after inclusion
measure: Intubation conditions assessment
timeFrame: between 1 hour to 3 hours after inclusion
measure: Need for alternate airway devices
timeFrame: between 1 hour to 3 hours after inclusion
measure: early intubation-related complications
timeFrame: between 1 hour to 3 hours after inclusion
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: CHU de La Réunion
state: La Réunion
city: Saint Pierre
country: France
facility: CHU de la Réunion
state: La Réunion
city: Bobigny
country: France
facility: CHU Avicenne
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Garches
country: France
facility: CHU Raymond Poincaré
city: Gonesse
country: France
facility: CH Gonesse
city: Lille
country: France
facility: CHRU de Lille
city: Melun
country: France
facility: CH Marc Jacquet
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: CHU Hôtel-Dieu
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: CHU Necker
city: Paris
country: France
facility: CHU Pitié-Salpêtrière
city: Pontoise
country: France
facility: CH René Dubos
city: Pringy
country: France
facility: CH Annecy
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital PURPAN
Study officials:
affiliation: CHU de La Réunion
name: Xavier Combes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guihard B, Chollet-Xemard C, Lakhnati P, Vivien B, Broche C, Savary D, Ricard-Hibon A, Marianne Dit Cassou PJ, Adnet F, Wiel E, Deutsch J, Tissier C, Loeb T, Bounes V, Rousseau E, Jabre P, Huiart L, Ferdynus C, Combes X. Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2303-2312. doi: 10.1001/jama.2019.18254.