Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

Shock Clinical Trial

— CURASMUR  

Official title:

Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000674
• Other study ID #: 2013/CHU/05
• Secondary ID: 2013-001438-16
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2013
• Last updated: December 14, 2017
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1321
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coma
• Emergencies
• Major Trauma
• Respiratory Distress
• Shock

Intervention

Drug:
• Succinylcholine : 1mg/kg

• Rocuronium : 1.2 mg/kg

Locations

Country	Name	City	State
France	CHU Avicenne	Bobigny
France	CHU Henri Mondor	Créteil
France	CHU de Dijon	Dijon
France	CHU Raymond Poincaré	Garches
France	CH Gonesse	Gonesse
France	CHRU de Lille	Lille
France	CH Marc Jacquet	Melun
France	CHU de Nîmes	Nîmes
France	CHU Hôtel-Dieu	Paris
France	CHU Lariboisière	Paris
France	CHU Necker	Paris
France	CHU Pitié-Salpêtrière	Paris
France	CH René Dubos	Pontoise
France	CH Annecy	Pringy
France	CHU de La Réunion	Saint Denis	La Réunion
France	CHU de la Réunion	Saint Pierre	La Réunion
France	CHU Toulouse - Hôpital PURPAN	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	SAMU de Paris, Hôpital Necker - Enfants Malades, Unité de Soutien Méthodologique (CHU de La Réunion)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-pass intubation success rate	Measured by the proportion of successful intubation in the first laryngoscopy.	between 1 hour to 3 hours after inclusion
Secondary	Incidence of difficult intubation	measured by the Intubation Difficulty Scale	between 1 hour to 3 hours after inclusion
Secondary	Intubation conditions assessment	using the Copenhagen score	between 1 hour to 3 hours after inclusion
Secondary	Need for alternate airway devices		between 1 hour to 3 hours after inclusion
Secondary	early intubation-related complications	complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest	between 1 hour to 3 hours after inclusion