Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study

Last updated: May 31, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

rapid sequence anesthetic induction

Clinical Study ID

NCT06194058
AR_2023_001
  • Ages > 18
  • All Genders

Study Summary

There is a great heterogeneity in the practice of rapid sequence induction in the operating room in the world. There are no recent data assessing the rate of implementation of the latest French formalized expert recommendations in clinical practice. In addition, the modalities for the management of haemodynamic disorders, particularly hypotensive disorders, during rapid sequence induction are not described in these recommendations, although these are frequent events with a non-zero morbidity mortality potential.

The goal of this prospective, observational, multicenter, anesthetic study is to describe the clinical practice of French anesthesiologists regarding the prevention of severe hemodynamic disorders during rapid sequence anesthetic induction in adult patients.

The primary outcome measure is the occurrence of a major haemodynamic disorder defined by a MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or the occurrence of sustained arrhythmia not present at induction and/or cardiac arrest within the first 10 minutes after induction of anesthesia.

The clinical practices of pre-oxygenation, induction and intubation of French anesthesiologists and compliance with the formalized expert recommendations of 2017 and 2018 will also be studied secondarily. The elements for the prevention of gastric fluid inhalation, the organization and equipment used, the anesthetic and non-anesthetic drugs used, the clinical and paraclinical neurological and cardio-respiratory parameters and the nature of the complications following anaesthetic induction will be collected up to the 10th post-induction minute.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years' old

  • Procedure requiring general anesthesia with oro or nasotracheal intubation

  • Anesthetic management with indication of rapid sequence induction

  • No objection after oral and written information to the patient

Exclusion

Exclusion Criteria:

  • Age < 18 years' old

  • Impossible intubation planned

  • Preoperative respiratory distress (SpO2 < 90% in ambient air)

  • Preoperative shock (MBP≤ 65 mmHg or vasopressive amines)

  • Preoperative coma defined by a Glasgow score ≤ 12/15

  • Patient in cardiopulmonary arrest

  • Patients under guardianship or curatorship

Study Design

Total Participants: 1150
Treatment Group(s): 1
Primary Treatment: rapid sequence anesthetic induction
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
May 15, 2025

Connect with a study center

  • Clinique Victor Pauchet

    Amiens,
    France

    Active - Recruiting

  • Hospital

    Arcachon,
    France

    Active - Recruiting

  • Hospital

    Armentières,
    France

    Active - Recruiting

  • Hôpital Privé Arras les Bonnettes

    Arras,
    France

    Active - Recruiting

  • University Hospital

    Brest,
    France

    Active - Recruiting

  • University Hospital

    Caen,
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal

    Castres,
    France

    Active - Recruiting

  • University Hospital

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • University Hospital

    Lille,
    France

    Site Not Available

  • Hospital

    Lorient,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Clinique de la Sauvegarde

    Lyon,
    France

    Active - Recruiting

  • Saint Joseph Saint Luc Hospital

    Lyon,
    France

    Active - Recruiting

  • University Hopital - Edouard Herriot

    Lyon,
    France

    Active - Recruiting

  • University Hospital - Sud

    Lyon,
    France

    Active - Recruiting

  • Hospital

    Mont-de-Marsan,
    France

    Site Not Available

  • Hospital

    Montargis,
    France

    Active - Recruiting

  • University Hospital

    Nantes,
    France

    Active - Recruiting

  • University Hospital - Pasteur

    Nice,
    France

    Active - Recruiting

  • Bichat Hospital - APHP

    Paris,
    France

    Active - Recruiting

  • Hopital Lariboisiere - APHP

    Paris,
    France

    Active - Recruiting

  • Hopital Pitié Salpetriere - APHP

    Paris,
    France

    Active - Recruiting

  • Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP

    Paris,
    France

    Active - Recruiting

  • Hôpital Tenon - APHP

    Paris,
    France

    Active - Recruiting

  • University Hospital

    Poitiers,
    France

    Site Not Available

  • Clinique de la Sagesse

    Rennes,
    France

    Active - Recruiting

  • Hospital

    Rodez,
    France

    Active - Recruiting

  • Yves Le Foll Hospital

    Saint brieuc,
    France

    Site Not Available

  • University Hospital La Réunion - Site Nord

    Saint-Denis,
    France

    Active - Recruiting

  • Hospital

    Saint-Malo,
    France

    Active - Recruiting

  • University Hospital La Réunion - site Ouest

    Saint-Paul,
    France

    Active - Recruiting

  • Groupe Hospitalier Seclin Carvin

    Seclin,
    France

    Site Not Available

  • Centre Clinical - Angoulême

    Soyaux,
    France

    Active - Recruiting

  • Clinique Rhéna

    Strasbourg,
    France

    Active - Recruiting

  • University Hospital - Hautepierre

    Strasbourg,
    France

    Active - Recruiting

  • Hôpitaux du Leman

    Thonon-les-Bains,
    France

    Active - Recruiting

  • Centre hospitalier intercommunal

    Toulon,
    France

    Active - Recruiting

  • University Hospital - Rangueil

    Toulouse,
    France

    Site Not Available

  • Hospital

    Valenciennes,
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

  • Clinique de Villeneuve Saint Georges

    Villeneuve-Saint-Georges,
    France

    Site Not Available

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