Clinical Trials Directory

Trials / Recruiting

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.

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,150 (estimated)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERrapid sequence anesthetic inductionRapid 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.

Timeline

Start date
2023-11-15
Primary completion
2024-11-15
Completion
2025-05-15
First posted
2024-01-08
Last updated
2024-06-03

Locations

42 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06194058. Inclusion in this directory is not an endorsement.