Optimisation Strategy for Emergency Tracheal Intubation

Last updated: July 17, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endotracheal Intubation

Treatment

Rapid sequence intubation (RSI) : Recommendations for emergency intubation

Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB

Data patient

Clinical Study ID

NCT05539391
CHUBX 2021/25
  • Ages > 18
  • All Genders

Study Summary

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient adult (≥ 18 years) presenting with vital distress requiring emergencytracheal intubation as assessed by the emergency physician in the out-of-hospitalsetting.

  • Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) exceptthose in cardiac arrest will be included.

Exclusion

Exclusion Criteria:

  • Patient presenting of a contraindication to succinylcholine, and/or rocuronium,and/or sugammadex (rocunorium antagonist).

  • Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis).

  • Patient that are not members of a medical aid scheme (beneficiary or main member).

  • Patient under specific protection measures: pregnant, parturient or nursing women;legal protection or deprived of liberty: patient under judicial protection, patientunder guardianship/curatorship.

Study Design

Total Participants: 1500
Treatment Group(s): 4
Primary Treatment: Rapid sequence intubation (RSI) : Recommendations for emergency intubation
Phase:
Study Start date:
January 14, 2023
Estimated Completion Date:
September 30, 2025

Study Description

Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.

Connect with a study center

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CH Carnelle Portes de l'Oise

    Beaumont-sur-Oise, 95260
    France

    Active - Recruiting

  • AP-HP - Hôpital Avicenne

    Bobigny, 93000
    France

    Active - Recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000
    France

    Active - Recruiting

  • Pellegrin Hospital

    Bordeaux, 33000
    France

    Active - Recruiting

  • CH de Pontoise René Dubos

    Cergy-Pontoise, 95303
    France

    Active - Recruiting

  • AP-HP - Hôpital Henri Mondor

    Créteil, 94000
    France

    Active - Recruiting

  • GH Eaubonne Montmorency Hôpital Simone VEIL

    Eaubonne, 95600
    France

    Site Not Available

  • AP-HP - Hôpital Raymond Poincaré

    Garches, 92380
    France

    Active - Recruiting

  • CHU de Grenoble - Hôpital Nord La Tronche

    La Tronche, 38700
    France

    Active - Recruiting

  • HCL - Hôpital Edouard Herriot

    Lyon, 69003
    France

    Active - Recruiting

  • GH Sud Ile de France

    Melun, 77000
    France

    Active - Recruiting

  • CHU de Montpellier Site Lapeyronie

    Montpellier, 34000
    France

    Active - Recruiting

  • CHU de Nantes - Hôpital Hôtel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • AP-HP - Hôpital Lariboisière

    Paris, 75013
    France

    Active - Recruiting

  • AP-HP - Hôpital Necker

    Paris, 75730
    France

    Site Not Available

  • AP-HP - Hôpital Pitié-Salpétrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86021
    France

    Active - Recruiting

  • CHU de la Réunion - Hôpital Felix Guyon

    Saint-Denis, 97400
    France

    Site Not Available

  • CHU de la Réunion - site Sud

    Saint-Pierre, 97448
    France

    Active - Recruiting

  • CHU Toulouse - Hôpital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

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