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Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

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ClinicalTrials.gov Identifier: NCT02000674
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Unité de Soutien Méthodologique (CHU de La Réunion)
SAMU de Paris, Hôpital Necker - Enfants Malades
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date December 15, 2017
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • Incidence of difficult intubation [ Time Frame: between 1 hour to 3 hours after inclusion ]
    measured by the Intubation Difficulty Scale
  • Intubation conditions assessment [ Time Frame: between 1 hour to 3 hours after inclusion ]
    using the Copenhagen score
  • Need for alternate airway devices [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Succinylcholine vs Rocuronium for Prehospital Emergency Intubation
Official Title  ICMJE Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Coma
  • Major Trauma
  • Respiratory Distress
  • Shock
Intervention  ICMJE
  • Drug: Succinylcholine : 1mg/kg
    Other Names:
    • Suxaméthonium Aguetant®
    • SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable
  • Drug: Rocuronium : 1.2 mg/kg
    Other Name: ESMERON®
Study Arms  ICMJE
  • Active Comparator: Administration of Succinylcholine
    Intubation after IV administration of Succinylcholine 1mg/kg
    Intervention: Drug: Succinylcholine : 1mg/kg
  • Experimental: Administration of Rocuronium
    Intubation after IV administration of Rocuronium 1.2 mg/kg
    Intervention: Drug: Rocuronium : 1.2 mg/kg
Publications * Guihard B, Chollet-Xémard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2017)
1321
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2013)
1300
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000674
Other Study ID Numbers  ICMJE 2013/CHU/05
2013-001438-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de la Réunion
Study Sponsor  ICMJE Centre Hospitalier Universitaire de la Réunion
Collaborators  ICMJE
  • Unité de Soutien Méthodologique (CHU de La Réunion)
  • SAMU de Paris, Hôpital Necker - Enfants Malades
Investigators  ICMJE
Principal Investigator: Xavier Combes, MD CHU de La Réunion
PRS Account Centre Hospitalier Universitaire de la Réunion
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP