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Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

NCT ID: NCT02000674

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Coma Major Trauma Respiratory Distress Shock

Keywords

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tracheal intubation pre hospital emergency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Administration of Succinylcholine

Intubation after IV administration of Succinylcholine 1mg/kg

Group Type ACTIVE_COMPARATOR

Succinylcholine : 1mg/kg

Intervention Type DRUG

Administration of Rocuronium

Intubation after IV administration of Rocuronium 1.2 mg/kg

Group Type EXPERIMENTAL

Rocuronium : 1.2 mg/kg

Intervention Type DRUG

Interventions

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Succinylcholine : 1mg/kg

Intervention Type DRUG

Rocuronium : 1.2 mg/kg

Intervention Type DRUG

Other Intervention Names

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Suxaméthonium Aguetant® SUXAMETHONIUM BIOCODEX 50 mg/ml, solution injectable ESMERON®

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unité de Soutien Méthodologique (CHU de La Réunion)

UNKNOWN

Sponsor Role collaborator

SAMU de Paris, Hôpital Necker - Enfants Malades

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Combes, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Locations

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CHU de La Réunion

Saint-Denis, La Réunion, France

Site Status

CHU de la Réunion

Saint-Pierre, La Réunion, France

Site Status

CHU Avicenne

Bobigny, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

CHU Raymond Poincaré

Garches, , France

Site Status

CH Gonesse

Gonesse, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

CH Marc Jacquet

Melun, , France

Site Status

CHU de Nîmes

Nîmes, , France

Site Status

CHU Hôtel-Dieu

Paris, , France

Site Status

CHU Lariboisière

Paris, , France

Site Status

CHU Necker

Paris, , France

Site Status

CHU Pitié-Salpêtrière

Paris, , France

Site Status

CH René Dubos

Pontoise, , France

Site Status

CH Annecy

Pringy, , France

Site Status

CHU Toulouse - Hôpital PURPAN

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31846014 (View on PubMed)

Other Identifiers

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2013-001438-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013/CHU/05

Identifier Type: -

Identifier Source: org_study_id