Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

December 14, 2017 updated by: Centre Hospitalier Universitaire de la Réunion

Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France
        • CHU Avicenne
      • Créteil, France
        • Chu Henri Mondor
      • Dijon, France
        • CHU de Dijon
      • Garches, France
        • CHU Raymond Poincaré
      • Gonesse, France
        • CH Gonesse
      • Lille, France
        • CHRU de Lille
      • Melun, France
        • CH Marc Jacquet
      • Nîmes, France
        • Chu de Nimes
      • Paris, France
        • Chu Lariboisiere
      • Paris, France
        • CHU Hôtel-Dieu
      • Paris, France
        • CHU Necker
      • Paris, France
        • CHU Pitié-Salpétrière
      • Pontoise, France
        • CH René Dubos
      • Pringy, France
        • CH Annecy
      • Toulouse, France
        • CHU toulouse - Hôpital Purpan
    • La Réunion
      • Saint Denis, La Réunion, France, 97405
        • CHU de La Réunion
      • Saint Pierre, La Réunion, France
        • CHU de La Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Administration of Succinylcholine
Intubation after IV administration of Succinylcholine 1mg/kg
Drug: Succinylcholine : 1mg/kg
Other Names:
  • Suxaméthonium Aguetant®
  • SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable
EXPERIMENTAL: Administration of Rocuronium
Intubation after IV administration of Rocuronium 1.2 mg/kg
Drug: Rocuronium : 1.2 mg/kg
Other Names:
  • ESMERON®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-pass intubation success rate
Time Frame: between 1 hour to 3 hours after inclusion
Measured by the proportion of successful intubation in the first laryngoscopy.
between 1 hour to 3 hours after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of difficult intubation
Time Frame: between 1 hour to 3 hours after inclusion
measured by the Intubation Difficulty Scale
between 1 hour to 3 hours after inclusion
Intubation conditions assessment
Time Frame: between 1 hour to 3 hours after inclusion
using the Copenhagen score
between 1 hour to 3 hours after inclusion
Need for alternate airway devices
Time Frame: between 1 hour to 3 hours after inclusion
between 1 hour to 3 hours after inclusion
early intubation-related complications
Time Frame: 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
between 1 hour to 3 hours after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Unité de Soutien Méthodologique (CHU de La Réunion)
SAMU de Paris, Hôpital Necker - Enfants Malades

Investigators

  • Principal Investigator: Xavier Combes, MD, CHU de La Réunion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (ESTIMATE)

December 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/CHU/05
  • 2013-001438-16 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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