NCT02000674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,321

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2013

Typical duration for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 15, 2017

Status Verified

March 1, 2017

Enrollment Period

2.6 years

First QC Date

October 9, 2013

Last Update Submit

December 14, 2017

Conditions

ComaMajor TraumaRespiratory DistressShock

Keywords

tracheal intubationpre hospital emergency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of difficult intubation

    between 1 hour to 3 hours after inclusion

  • Intubation conditions assessment

    between 1 hour to 3 hours after inclusion

  • Need for alternate airway devices

    between 1 hour to 3 hours after inclusion

  • early intubation-related complications

    between 1 hour to 3 hours after inclusion

Study Arms (2)

Administration of Succinylcholine

ACTIVE COMPARATOR

Intubation after IV administration of Succinylcholine 1mg/kg

Drug: Succinylcholine : 1mg/kg

Administration of Rocuronium

EXPERIMENTAL

Intubation after IV administration of Rocuronium 1.2 mg/kg

Drug: Rocuronium : 1.2 mg/kg

Interventions

Succinylcholine : 1mg/kgDRUG
Also known as: Suxaméthonium Aguetant®, SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable
Administration of Succinylcholine
Rocuronium : 1.2 mg/kgDRUG
Also known as: ESMERON®
Administration of Rocuronium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU de La Réunion

Saint-Denis, La Réunion, 97405, France

Location

CHU de la Réunion

Saint-Pierre, La Réunion, France

Location

CHU Avicenne

Bobigny, France

Location

CHU Henri Mondor

Créteil, France

Location

CHU de Dijon

Dijon, France

Location

CHU Raymond Poincaré

Garches, France

Location

CH Gonesse

Gonesse, France

Location

CHRU de Lille

Lille, France

Location

CH Marc Jacquet

Melun, France

Location

CHU de Nîmes

Nîmes, France

Location

CHU Hôtel-Dieu

Paris, France

Location

CHU Lariboisière

Paris, France

Location

CHU Necker

Paris, France

Location

CHU Pitié-Salpêtrière

Paris, France

Location

CH René Dubos

Pontoise, France

Location

CH Annecy

Pringy, France

Location

CHU Toulouse - Hôpital PURPAN

Toulouse, France

Location

Related Publications (1)

  • 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.

    PMID: 31846014DERIVED

MeSH Terms

Conditions

ComaDyspneaShock

Interventions

SuccinylcholineRocuronium

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryPathologic Processes

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOnium CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xavier Combes, MD

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

December 4, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 15, 2017

Record last verified: 2017-03

Locations

FR(17)