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Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

Primary Purpose

Coma, Major Trauma, Respiratory Distress

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Succinylcholine : 1mg/kg
Rocuronium : 1.2 mg/kg
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coma focused on measuring tracheal intubation, pre hospital emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU de La Réunion
  • CHU de la Réunion
  • CHU Avicenne
  • CHU Henri Mondor
  • CHU de Dijon
  • CHU Raymond Poincaré
  • CH Gonesse
  • CHRU de Lille
  • CH Marc Jacquet
  • CHU de Nîmes
  • CHU Hôtel-Dieu
  • CHU Lariboisière
  • CHU Necker
  • CHU Pitié-Salpêtrière
  • CH René Dubos
  • CH Annecy
  • CHU Toulouse - Hôpital PURPAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Administration of Succinylcholine

Administration of Rocuronium

Arm Description

Intubation after IV administration of Succinylcholine 1mg/kg

Intubation after IV administration of Rocuronium 1.2 mg/kg

Outcomes

Primary Outcome Measures

First-pass intubation success rate
Measured by the proportion of successful intubation in the first laryngoscopy.

Secondary Outcome Measures

Incidence of difficult intubation
measured by the Intubation Difficulty Scale
Intubation conditions assessment
using the Copenhagen score
Need for alternate airway devices
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

Full Information

First Posted
October 9, 2013
Last Updated
December 14, 2017
Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Unité de Soutien Méthodologique (CHU de La Réunion), SAMU de Paris, Hôpital Necker - Enfants Malades
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1. Study Identification

Unique Protocol Identification Number
NCT02000674
Brief Title
Succinylcholine vs Rocuronium for Prehospital Emergency Intubation
Acronym
CURASMUR
Official Title
Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Unité de Soutien Méthodologique (CHU de La Réunion), SAMU de Paris, Hôpital Necker - Enfants Malades

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma, Major Trauma, Respiratory Distress, Shock
Keywords
tracheal intubation, pre hospital emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of Succinylcholine
Arm Type
Active Comparator
Arm Description
Intubation after IV administration of Succinylcholine 1mg/kg
Arm Title
Administration of Rocuronium
Arm Type
Experimental
Arm Description
Intubation after IV administration of Rocuronium 1.2 mg/kg
Intervention Type
Drug
Intervention Name(s)
Succinylcholine : 1mg/kg
Other Intervention Name(s)
Suxaméthonium Aguetant®, SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable
Intervention Type
Drug
Intervention Name(s)
Rocuronium : 1.2 mg/kg
Other Intervention Name(s)
ESMERON®
Primary Outcome Measure Information:
Title
First-pass intubation success rate
Description
Measured by the proportion of successful intubation in the first laryngoscopy.
Time Frame
between 1 hour to 3 hours after inclusion
Secondary Outcome Measure Information:
Title
Incidence of difficult intubation
Description
measured by the Intubation Difficulty Scale
Time Frame
between 1 hour to 3 hours after inclusion
Title
Intubation conditions assessment
Description
using the Copenhagen score
Time Frame
between 1 hour to 3 hours after inclusion
Title
Need for alternate airway devices
Time Frame
between 1 hour to 3 hours after inclusion
Title
early intubation-related complications
Description
complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest
Time Frame
between 1 hour to 3 hours after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Combes, MD
Organizational Affiliation
CHU de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de La Réunion
City
Saint Denis
State/Province
La Réunion
ZIP/Postal Code
97405
Country
France
Facility Name
CHU de la Réunion
City
Saint Pierre
State/Province
La Réunion
Country
France
Facility Name
CHU Avicenne
City
Bobigny
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU Raymond Poincaré
City
Garches
Country
France
Facility Name
CH Gonesse
City
Gonesse
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
CH Marc Jacquet
City
Melun
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Facility Name
CHU Hôtel-Dieu
City
Paris
Country
France
Facility Name
CHU Lariboisière
City
Paris
Country
France
Facility Name
CHU Necker
City
Paris
Country
France
Facility Name
CHU Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
CH René Dubos
City
Pontoise
Country
France
Facility Name
CH Annecy
City
Pringy
Country
France
Facility Name
CHU Toulouse - Hôpital PURPAN
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31846014
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.
Results Reference
derived

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Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

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