RecruitingNCT06194058

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

Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study. The Crush or Crash Study.


Sponsor

Nantes University Hospital

Enrollment

1,150 participants

Start Date

Nov 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

OTHERrapid 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.


Locations(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

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NCT06194058


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