Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
CoC
1 other identifier
observational
1,150
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
42 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2025
CompletedJune 3, 2024
May 1, 2024
1 year
November 14, 2023
May 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of a major haemodynamic disorder
MBP ≤ 50 mmHg (or ≤ 40% of the reference value) and/or ≥ 110 mmHg and/or occurrence of a sustained arrhythmia (\> 1 min) not present at induction and/or cardiac arrest
Within the first 10 minutes after induction of anesthesia
Secondary Outcomes (25)
Clinical pre-anesthesic assessment of the risk of a full stomach
From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
Pre-anesthetic assessment of the risk of a full stomach
From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
Assessment of the risk of a full stomach
From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
Team involved in the rapid sequence induction technique
Within the first 10 minutes after induction of anesthesia
Preparation for rapide sequence induction technique
Within the first 10 minutes after induction of anesthesia
- +20 more secondary outcomes
Interventions
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.
Eligibility Criteria
All adult patients for whom rapid sequence anesthetic induction has been retained in the operating room and for whom no opposition has been obtained during the anesthesia consultation will be included consecutively.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Clinique Victor Pauchet
Amiens, France
Hospital
Arcachon, France
Hospital
Armentières, France
Hôpital Privé Arras les Bonnettes
Arras, France
University Hospital
Brest, France
University Hospital
Caen, France
Centre Hospitalier Intercommunal
Castres, France
University Hospital
Clermont-Ferrand, France
CHD Vendée
La Roche-sur-Yon, France
University Hospital
Lille, France
Hospital
Lorient, France
Centre Léon Bérard
Lyon, France
Clinique de la Sauvegarde
Lyon, France
Saint Joseph Saint Luc Hospital
Lyon, France
University Hopital - Edouard Herriot
Lyon, France
University Hospital - Sud
Lyon, France
Hospital
Mont-de-Marsan, France
Hospital
Montargis, France
University Hospital
Nantes, France
University Hospital - Pasteur
Nice, France
Bichat Hospital - APHP
Paris, France
Hopital Lariboisiere - APHP
Paris, France
Hopital Pitié Salpetriere - APHP
Paris, France
Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP
Paris, France
Hôpital Tenon - APHP
Paris, France
University Hospital
Poitiers, France
Clinique de la Sagesse
Rennes, France
Hospital
Rodez, France
Yves Le Foll Hospital
Saint-Brieuc, France
University Hospital La Réunion - Site Nord
Saint-Denis, France
University Hospital La Réunion - site Ouest
Saint-Paul, France
Groupe Hospitalier Seclin Carvin
Seclin, France
Centre Clinical - Angoulême
Soyaux, France
Hospital
St-Malo, France
Clinique Rhéna
Strasbourg, France
University Hospital - Hautepierre
Strasbourg, France
Hôpitaux du Leman
Thonon-les-Bains, France
Centre hospitalier intercommunal
Toulon, France
University Hospital - Rangueil
Toulouse, France
Hospital
Valenciennes, France
Institut Gustave Roussy
Villejuif, France
Clinique de Villeneuve Saint Georges
Villeneuve-Saint-Georges, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas Grillot, MD
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2023
First Posted
January 8, 2024
Study Start
November 15, 2023
Primary Completion
November 15, 2024
Study Completion
May 15, 2025
Last Updated
June 3, 2024
Record last verified: 2024-05