Trial record 12 of 29 for:    Open Studies | "Coma"

Succinylcholine vs Rocuronium for Prehospital Emergency Intubation (CURASMUR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Hospitalier Universitaire de la Réunion
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
ClinicalTrials.gov Identifier:
NCT02000674
First received: October 9, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coma
Major Trauma
Respiratory Distress
Shock
Drug: Succinylcholine : 1mg/kg
Drug: Rocuronium : 1.2 mg/kg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:
  • First-pass intubation success rate [ Time Frame: between 1 hour to 3 hours after inclusion ] [ Designated as safety issue: No ]
    Measured by the proportion of successful intubation in the first laryngoscopy.


Secondary Outcome Measures:
  • Incidence of difficult intubation [ Time Frame: between 1 hour to 3 hours after inclusion ] [ Designated as safety issue: No ]
    measured by the Intubation Difficulty Scale

  • Intubation conditions assessment [ Time Frame: between 1 hour to 3 hours after inclusion ] [ Designated as safety issue: No ]
    using the Copenhagen score

  • Need for alternate airway devices [ Time Frame: between 1 hour to 3 hours after inclusion ] [ Designated as safety issue: No ]
  • early intubation-related complications [ Time Frame: between 1 hour to 3 hours after inclusion ] [ Designated as safety issue: No ]
    complications : esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest


Estimated Enrollment: 1300
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Administration of Succinylcholine
Intubation after IV administration of Succinylcholine 1mg/kg
Drug: Succinylcholine : 1mg/kg
Other Name: Suxaméthonium Aguetant®
Experimental: Administration of Rocuronium
Intubation after IV administration of Rocuronium 1.2 mg/kg
Drug: Rocuronium : 1.2 mg/kg
Other Name: ESMERON®

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000674

Contacts
Contact: Xavier Combes 02 62 90 60 46 x.combes.samu974@chu-reunion.fr
Contact: Vanessa Basque 02 62 35 95 25 vanessa.basque@chu-reunion.fr

Locations
France
CHU de La Réunion Recruiting
Saint Denis, La Réunion, France, 97405
Contact: Xavier Combes    02 62 90 20 72    x.combes.samu974@chu-reunion.fr   
Principal Investigator: Xavier Combes         
Sub-Investigator: Marielle BASTY-GHUYSEN         
Sub-Investigator: Pascal BAUDON         
Sub-Investigator: Laurent CHEN-CHI-SONG         
Sub-Investigator: Francois DALTROFF         
Sub-Investigator: Amelie DARMEDRU         
Sub-Investigator: Emilie FENETRIER         
Sub-Investigator: Magali FERRY         
Sub-Investigator: Bertrand GUIHARD         
Sub-Investigator: Nasser LAKEBAL         
Sub-Investigator: Arnaud MICHALON         
Sub-Investigator: Sophie PREDOUR         
Sub-Investigator: Anna SALNIKOVA         
Sub-Investigator: Jerome SUDRIAL         
Sub-Investigator: Frederic NATIVEL, MD         
CHU de la Réunion Recruiting
Saint Pierre, La Réunion, France
Contact: Pierre Jean Marianne       pierre-jean.marianne-cassou@chu-reunion.fr   
Principal Investigator: Pierre Jean Marianne         
Sub-Investigator: Thibault ADENIS         
Sub-Investigator: Perine BOURDIN         
Sub-Investigator: Hakim CHABANE         
Sub-Investigator: Thomas MASSEGUIN         
Sub-Investigator: Flore PINEAU         
Sub-Investigator: Antoine POUPEL         
Sub-Investigator: Adrien VAGUE         
Sub-Investigator: Lena GUILLOU, MD         
Sub-Investigator: Tatjana JEKIC, MD         
Sub-Investigator: Paul LAFORET, MD         
Sub-Investigator: Marion LENOIR, MD         
Sub-Investigator: Catherine MANGIN, MD         
Sub-Investigator: Jean Manuel PIERNA, MD         
Sub-Investigator: Roland RAKOTOSON, MD         
CHU Avicenne Not yet recruiting
Bobigny, France
Contact: Hayatte Akodad, MD       hayatte.akodad@gmail.com   
Principal Investigator: Hayatte Akodad, MD         
CHU Henri Mondor Recruiting
Créteil, France
Contact: Charlotte Chollet-Xémard, MD       charlotte.chollet@hmn.aphp.fr   
Principal Investigator: Charlotte CHOLLET-XEMARD, MD         
CHU de Dijon Not yet recruiting
Dijon, France
Contact: Marc Freysz, MD       marc.freysz@chu-dijon.fr   
CHU Raymond Poincaré Not yet recruiting
Garches, France
Contact: Thomas Loeb       thomas.loeb@rpc.aphp.fr   
CH Gonesse Recruiting
Gonesse, France
Contact: philippe lakhnati, MD       philippe.lakhnati@gmail.com   
Principal Investigator: Philippe LAKHNATI, MD         
CHRU de Lille Not yet recruiting
Lille, France
Contact: eric wiel, MD       eric.wiel@chru-lille.fr   
CH Marc Jacquet Recruiting
Melun, France
Contact: Laurent Rebillard, MD       laurent.rebillard@ch-melun.fr   
Principal Investigator: Laurent Rebillard, MD         
CHU de Nîmes Not yet recruiting
Nîmes, France
Contact: Xavier Bobbia, MD       xavier.bobbia@chu-nimes.fr   
CHU Lariboisière Not yet recruiting
Paris, France
Contact: Papa Gueye, MD       papa.gueye@lrb.aphp.fr   
CHU de l'Hôtel-Dieu Not yet recruiting
Paris, France
Contact: Gerald Kierzek, MD       gerald.kierzek@htd.aphp.fr   
CHU Pitié-Salpêtrière Recruiting
Paris, France
Contact: Patrick Ecollan, MD       patrick.ecollan@psl.aphp.fr   
Principal Investigator: Patrick ECOLLAN, MD         
CHU Necker Recruiting
Paris, France
Contact: Benoit Vivien, MD       benoit.vivien@nck.aphp.fr   
CH René Dubos Recruiting
Pontoise, France
Contact: Agnès Ricard-Hibon, MD       agnes.ricard-hibon@ch-pontoise.fr   
Principal Investigator: Agnès RICARD-HIBON, MD         
CH Annecy Not yet recruiting
Pringy, France
Contact: Dominique Savary, MD       dsavary@ch-annecy.fr   
CHU Toulouse - Hôpital PURPAN Not yet recruiting
Toulouse, France
Contact: Vincent Bounes, MD       bounes.v@chu-toulouse.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02000674     History of Changes
Other Study ID Numbers: 2013/CHU/05, 2013-001438-16
Study First Received: October 9, 2013
Last Updated: July 24, 2014
Health Authority: France: Angence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
tracheal intubation
pre hospital emergency

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on September 18, 2014