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

NCT ID: NCT06194058

Last Updated: 2024-06-03

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

RECRUITING

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rapid Sequence Intubation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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rapid sequence anesthetic induction

Rapid sequence induction and intubation (or crash induction) is a process for inducing general anesthesia when the patient is at a high risk of pulmonary aspiration. It aims at minimizing the time between giving the induction drugs and securing the tube, during which period the patient's airway is essentially unprotected.

Intervention Type OTHER

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Grillot, MD

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

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Clinique Victor Pauchet

Amiens, , France

Site Status RECRUITING

Hospital

Arcachon, , France

Site Status RECRUITING

Hospital

Armentières, , France

Site Status RECRUITING

Hôpital Privé Arras les Bonnettes

Arras, , France

Site Status RECRUITING

University Hospital

Brest, , France

Site Status RECRUITING

University Hospital

Caen, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal

Castres, , France

Site Status RECRUITING

University Hospital

Clermont-Ferrand, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

University Hospital

Lille, , France

Site Status NOT_YET_RECRUITING

Hospital

Lorient, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Clinique de la Sauvegarde

Lyon, , France

Site Status RECRUITING

Saint Joseph Saint Luc Hospital

Lyon, , France

Site Status RECRUITING

University Hopital - Edouard Herriot

Lyon, , France

Site Status RECRUITING

University Hospital - Sud

Lyon, , France

Site Status RECRUITING

Hospital

Mont-de-Marsan, , France

Site Status NOT_YET_RECRUITING

Hospital

Montargis, , France

Site Status RECRUITING

University Hospital

Nantes, , France

Site Status RECRUITING

University Hospital - Pasteur

Nice, , France

Site Status RECRUITING

Bichat Hospital - APHP

Paris, , France

Site Status RECRUITING

Hopital Lariboisiere - APHP

Paris, , France

Site Status RECRUITING

Hopital Pitié Salpetriere - APHP

Paris, , France

Site Status RECRUITING

Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP

Paris, , France

Site Status RECRUITING

Hôpital Tenon - APHP

Paris, , France

Site Status RECRUITING

University Hospital

Poitiers, , France

Site Status NOT_YET_RECRUITING

Clinique de la Sagesse

Rennes, , France

Site Status RECRUITING

Hospital

Rodez, , France

Site Status RECRUITING

Yves Le Foll Hospital

Saint-Brieuc, , France

Site Status NOT_YET_RECRUITING

University Hospital La Réunion - Site Nord

Saint-Denis, , France

Site Status RECRUITING

University Hospital La Réunion - site Ouest

Saint-Paul, , France

Site Status RECRUITING

Groupe Hospitalier Seclin Carvin

Seclin, , France

Site Status NOT_YET_RECRUITING

Centre Clinical - Angoulême

Soyaux, , France

Site Status RECRUITING

Hospital

St-Malo, , France

Site Status RECRUITING

Clinique Rhéna

Strasbourg, , France

Site Status RECRUITING

University Hospital - Hautepierre

Strasbourg, , France

Site Status RECRUITING

Hôpitaux du Leman

Thonon-les-Bains, , France

Site Status RECRUITING

Centre hospitalier intercommunal

Toulon, , France

Site Status RECRUITING

University Hospital - Rangueil

Toulouse, , France

Site Status NOT_YET_RECRUITING

Hospital

Valenciennes, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status NOT_YET_RECRUITING

Clinique de Villeneuve Saint Georges

Villeneuve-Saint-Georges, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Hugo Ingles, MD

Role: CONTACT

+33.2.40.08.73.80

Nicolas Grillot, MD

Role: CONTACT

+33.2.40.08.73.80

Facility Contacts

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Pierre Huette

Role: primary

Jeremy Allary

Role: primary

Lucile Debaecker

Role: primary

Matthias Garrot

Role: primary

Anais Caillard

Role: primary

Valentin Lefrancois

Role: primary

Mathilde Vernet

Role: primary

Thomas Godet

Role: primary

Mathieu Oudot

Role: primary

Victor Lestrade

Role: primary

Seamus Thierry

Role: primary

Grégoire Wallon

Role: primary

Olivier Desebbe

Role: primary

Mathieu Fontaine

Role: primary

Emma Aka

Role: primary

Marc Bouchet

Role: primary

Andersen Ramorasata

Role: primary

Ahiab Alnumier

Role: primary

Hugo Ingles

Role: primary

Victor Gridel

Role: primary

Aurélie Gouel

Role: primary

Sophie Dagois

Role: primary

Dimitri Margetis

Role: primary

Anouare Friaa

Role: primary

Gauthier Hamon

Role: primary

Quentin Saint Genis

Role: primary

Stéphanie Chevalier

Role: primary

Julie Delmas

Role: primary

Lauren Daviet

Role: primary

Laurent Thiltges

Role: primary

Alexis Carpentier

Role: primary

Alexandre Turbelin

Role: primary

Gianluca Caragliano

Role: primary

Guillaume Allo

Role: primary

Nadège Erb

Role: primary

Julie Gaudefroy

Role: primary

Caroline Gauthier

Role: primary

Sophie Prieur

Role: primary

Vincent Pey

Role: primary

Fanny Cointre

Role: primary

Jamie Elmawieh

Role: primary

Virginie Trehel-Tursis

Role: primary

Other Identifiers

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AR_2023_001

Identifier Type: -

Identifier Source: org_study_id

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