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

May 31, 2024 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • Clinique Victor Pauchet
        • Contact:
          • Pierre Huette
      • Arcachon, France
      • Armentières, France
      • Arras, France
        • Recruiting
        • Hopital Privé Arras les Bonnettes
        • Contact:
          • Matthias Garrot
      • Brest, France
        • Recruiting
        • University Hospital
        • Contact:
          • Anais CAILLARD
      • Caen, France
      • Castres, France
      • Clermont-Ferrand, France
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendee
        • Contact:
          • Mathieu OUDOT
      • Lille, France
        • Not yet recruiting
        • University Hospital
        • Contact:
          • Victor Lestrade
      • Lorient, France
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Grégoire Wallon
      • Lyon, France
        • Recruiting
        • Clinique de la Sauvegarde
        • Contact:
          • Olivier Desebbe
      • Lyon, France
      • Lyon, France
      • Lyon, France
      • Mont-de-Marsan, France
      • Montargis, France
      • Nantes, France
        • Recruiting
        • University Hospital
        • Contact:
          • Hugo Ingles
      • Nice, France
      • Paris, France
      • Paris, France
        • Recruiting
        • Hôpital Tenon - APHP
        • Contact:
          • Gauthier Hamon
      • Paris, France
      • Paris, France
      • Paris, France
        • Recruiting
        • Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP
        • Contact:
      • Poitiers, France
      • Rennes, France
      • Rodez, France
      • Saint brieuc, France
      • Saint-Denis, France
      • Saint-Malo, France
      • Saint-Paul, France
        • Recruiting
        • University Hospital La Réunion - site Ouest
        • Contact:
      • Seclin, France
      • Soyaux, France
        • Recruiting
        • Centre Clinical - Angoulême
        • Contact:
          • Gianluca Caragliano
      • Strasbourg, France
        • Recruiting
        • Clinique Rhéna
        • Contact:
          • Nadège Erb
      • Strasbourg, France
      • Thonon-les-Bains, France
      • Toulon, France
      • Toulouse, France
      • Valenciennes, France
        • Recruiting
        • Hospital
        • Contact:
          • Fanny Cointre
      • Villejuif, France
      • Villeneuve-Saint-Georges, France
        • Not yet recruiting
        • Clinique de Villeneuve Saint Georges
        • Contact:
          • Virginie Trehel-Tursis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of a major haemodynamic disorder
Time Frame: Within the first 10 minutes after induction of anesthesia
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pre-anesthesic assessment of the risk of a full stomach
Time Frame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
- percentage of clinical and/or imaging endpoints in favor 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
Time Frame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
- percentage of gastric ultrasound use
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
Time Frame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
- percentage of presence and use of the Nasogastric Tube
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
Time Frame: Within the first 10 minutes after induction of anesthesia
- average number of individuals in the room participating in the performance of SRI
Within the first 10 minutes after induction of anesthesia
Preparation for rapide sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- Percentage of patients in supine position
Within the first 10 minutes after induction of anesthesia
Use of morphine for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of use of morphine derivative prior to airway securisation
Within the first 10 minutes after induction of anesthesia
Induction therapeutics for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of use of each of the following hypnotics: propofol, ketamine, thiopental, etomidate, midazolam, sevoflurane
Within the first 10 minutes after induction of anesthesia
Use of curare for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of use of a curare
Within the first 10 minutes after induction of anesthesia
Use of vasopressive amine for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage and median dosage of vasopressive amine use for the prevention of low blood pressure
Within the first 10 minutes after induction of anesthesia
Use of filling solution for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage and median volume of use of a preventive vascular filling solution
Within the first 10 minutes after induction of anesthesia
Airway management for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- type of preoxygenation
Within the first 10 minutes after induction of anesthesia
Operator qualification for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentages of first operator with a medical degree, of trained nurses, and of medical resident performing the rapid sequence induction technique
Within the first 10 minutes after induction of anesthesia
Laryngoscopy for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of use of a video laryngoscope as a 1st intention
Within the first 10 minutes after induction of anesthesia
Medical device used for rapid sequence induction technique
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of mandrel use at the first laryngoscopy
Within the first 10 minutes after induction of anesthesia
MBP complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of episode of MBP ≤ at 50 mmHg (or ≤ 40% of the baseline)
Within the first 10 minutes after induction of anesthesia
Tension complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of episode of MBP ≥ 110 mmHg
Within the first 10 minutes after induction of anesthesia
Rythmal complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- sustained arrhythmia (> 1 minute) not present at induction
Within the first 10 minutes after induction of anesthesia
Cardiac complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- cardiac arrest
Within the first 10 minutes after induction of anesthesia
Intubation complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of intubations that required more than one laryngoscopy
Within the first 10 minutes after induction of anesthesia
Low tension-related complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage and median dosage of use of a vasopressive amine required for the treatment of low blood pressure (defined as a SBP < 80 mmHg)
Within the first 10 minutes after induction of anesthesia
High tension-related complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of use of an antihypertensive drug or sedation-analgesia bolus for the treatment of high blood pressure (defined as SBP > 160 mmHg)
Within the first 10 minutes after induction of anesthesia
Respiratory complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of respiratory complication defined by Spo2 < 90% or the need for manual reventilation
Within the first 10 minutes after induction of anesthesia
Anaphylactic complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of Grade I, II, III or IV anaphylactic reaction
Within the first 10 minutes after induction of anesthesia
Inhalation complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of gastric fluid inhalation defined by the presence of non-salivary fluid or supraglottic solids during laryngoscopy
Within the first 10 minutes after induction of anesthesia
Immediate complications of ISR (< 10 minutes)
Time Frame: Within the first 10 minutes after induction of anesthesia
- percentage of intraoperative deaths
Within the first 10 minutes after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Société Française d'Anesthésie et de Réanimation

Investigators

  • Study Director: Nicolas Grillot, MD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR_2023_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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