Actively Recruiting

Age: 18Years +
All Genders
NCT06194058

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

Led by Nantes University Hospital · Updated on 2024-06-03

1150

Participants Needed

42

Research Sites

78 weeks

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

S

Société Française d'Anesthésie et de Réanimation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • 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
Not Eligible

You will not qualify if you...

  • Age younger than 18 years
  • Planned impossible intubation
  • Preoperative respiratory distress with oxygen saturation below 90% in ambient air
  • Preoperative shock with mean blood pressure 65 mmHg or lower or use of vasopressive medications
  • Preoperative coma with Glasgow score 12/15 or lower
  • Patient in cardiopulmonary arrest
  • Patients under guardianship or curatorship

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 42 locations

1

Clinique Victor Pauchet

Amiens, France

Actively Recruiting

2

Hospital

Arcachon, France

Actively Recruiting

3

Hospital

Armentières, France

Actively Recruiting

4

Hôpital Privé Arras les Bonnettes

Arras, France

Actively Recruiting

5

University Hospital

Brest, France

Actively Recruiting

6

University Hospital

Caen, France

Actively Recruiting

7

Centre Hospitalier Intercommunal

Castres, France

Actively Recruiting

8

University Hospital

Clermont-Ferrand, France

Actively Recruiting

9

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

10

University Hospital

Lille, France

Not Yet Recruiting

11

Hospital

Lorient, France

Actively Recruiting

12

Centre Léon Bérard

Lyon, France

Actively Recruiting

13

Clinique de la Sauvegarde

Lyon, France

Actively Recruiting

14

Saint Joseph Saint Luc Hospital

Lyon, France

Actively Recruiting

15

University Hopital - Edouard Herriot

Lyon, France

Actively Recruiting

16

University Hospital - Sud

Lyon, France

Actively Recruiting

17

Hospital

Mont-de-Marsan, France

Not Yet Recruiting

18

Hospital

Montargis, France

Actively Recruiting

19

University Hospital

Nantes, France

Actively Recruiting

20

University Hospital - Pasteur

Nice, France

Actively Recruiting

21

Bichat Hospital - APHP

Paris, France

Actively Recruiting

22

Hopital Lariboisiere - APHP

Paris, France

Actively Recruiting

23

Hopital Pitié Salpetriere - APHP

Paris, France

Actively Recruiting

24

Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP

Paris, France

Actively Recruiting

25

Hôpital Tenon - APHP

Paris, France

Actively Recruiting

26

University Hospital

Poitiers, France

Not Yet Recruiting

27

Clinique de la Sagesse

Rennes, France

Actively Recruiting

28

Hospital

Rodez, France

Actively Recruiting

29

Yves Le Foll Hospital

Saint-Brieuc, France

Not Yet Recruiting

30

University Hospital La Réunion - Site Nord

Saint-Denis, France

Actively Recruiting

31

University Hospital La Réunion - site Ouest

Saint-Paul, France

Actively Recruiting

32

Groupe Hospitalier Seclin Carvin

Seclin, France

Not Yet Recruiting

33

Centre Clinical - Angoulême

Soyaux, France

Actively Recruiting

34

Hospital

St-Malo, France

Actively Recruiting

35

Clinique Rhéna

Strasbourg, France

Actively Recruiting

36

University Hospital - Hautepierre

Strasbourg, France

Actively Recruiting

37

Hôpitaux du Leman

Thonon-les-Bains, France

Actively Recruiting

38

Centre hospitalier intercommunal

Toulon, France

Actively Recruiting

39

University Hospital - Rangueil

Toulouse, France

Not Yet Recruiting

40

Hospital

Valenciennes, France

Actively Recruiting

41

Institut Gustave Roussy

Villejuif, France

Not Yet Recruiting

42

Clinique de Villeneuve Saint Georges

Villeneuve-Saint-Georges, France

Not Yet Recruiting

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Research Team

H

Hugo Ingles, MD

CONTACT

N

Nicolas Grillot, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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