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ClinicalTrials.gov ID

NCT06194058

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,150Estimated

Last Update Posted

Jun 3, 2024Actual

Start Date

Nov 15, 2023Actual

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

May 15, 2025Estimated

Official Title

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

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.

• Rapid Sequence Intubation

• rapid sequence anesthetic induction

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

Société Française d'Anesthésie et de RéanimationOTHER

Jeremy.Allary@ch-arcachon.fr

l.debaecker@ch-armentieres.fr

s.thierry@ghbs.bzh

aalnumier@ch-montargis.fr

J.DELMAS@ch-rodez.fr

G.ALLO@ch-stmalo.fr