Clinical trial NCT06194058: Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
Official title: Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study. The Crush or Crash Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rapid Sequence Intubation
Keywords: anesthetic induction
adult patients
hemodynamic disorders
arrythmia
cardiac arrest
pre-oxygenation
mean blood pressure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie et de Réanimation
First posted: 2024-01-08
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Occurrence of a major haemodynamic disorder
timeFrame: Within the first 10 minutes after induction of anesthesia
Secondary outcomes:
measure: Clinical pre-anesthesic assessment of the risk of a full stomach
timeFrame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
measure: Pre-anesthetic assessment of the risk of a full stomach
timeFrame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
measure: Assessment of the risk of a full stomach
timeFrame: From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
measure: Team involved in the rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Preparation for rapide sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Use of morphine for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Induction therapeutics for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Use of curare for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Use of vasopressive amine for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Use of filling solution for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Airway management for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Operator qualification for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Laryngoscopy for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Medical device used for rapid sequence induction technique
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: MBP complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Tension complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Rythmal complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Cardiac complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Intubation complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Low tension-related complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: High tension-related complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Respiratory complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Anaphylactic complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Inhalation complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
measure: Immediate complications of ISR (< 10 minutes)
timeFrame: Within the first 10 minutes after induction of anesthesia
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique Victor Pauchet
city: Arcachon
country: France
facility: Hospital
city: Armentières
country: France
facility: Hospital
city: Arras
country: France
facility: Hôpital Privé Arras les Bonnettes
city: Brest
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Castres
country: France
facility: Centre Hospitalier Intercommunal
city: Clermont-Ferrand
country: France
facility: University Hospital
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: University Hospital
city: Lorient
country: France
facility: Hospital
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Saint Joseph Saint Luc Hospital
city: Lyon
country: France
facility: University Hopital - Edouard Herriot
city: Lyon
country: France
facility: University Hospital - Sud
city: Mont-de-Marsan
country: France
facility: Hospital
city: Montargis
country: France
facility: Hospital
city: Nantes
country: France
facility: University Hospital
city: Nice
country: France
facility: University Hospital - Pasteur
city: Paris
country: France
facility: Bichat Hospital - APHP
city: Paris
country: France
facility: Hopital Lariboisiere - APHP
city: Paris
country: France
facility: Hopital Pitié Salpetriere - APHP
city: Paris
country: France
facility: Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP
city: Paris
country: France
facility: Hôpital Tenon - APHP
city: Poitiers
country: France
facility: University Hospital
city: Rennes
country: France
facility: Clinique de la Sagesse
city: Rodez
country: France
facility: Hospital
city: Saint brieuc
country: France
facility: Yves Le Foll Hospital
city: Saint-Denis
country: France
facility: University Hospital La Réunion - Site Nord
city: Saint-Malo
country: France
facility: Hospital
city: Saint-Paul
country: France
facility: University Hospital La Réunion - site Ouest
city: Seclin
country: France
facility: Groupe Hospitalier Seclin Carvin
city: Soyaux
country: France
facility: Centre Clinical - Angoulême
city: Strasbourg
country: France
facility: Clinique Rhéna
city: Strasbourg
country: France
facility: University Hospital - Hautepierre
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Leman
city: Toulon
country: France
facility: Centre hospitalier intercommunal
city: Toulouse
country: France
facility: University Hospital - Rangueil
city: Valenciennes
country: France
facility: Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeneuve-Saint-Georges
country: France
facility: Clinique de Villeneuve Saint Georges
Study officials:
affiliation: Nantes University Hospital
name: Nicolas Grillot, MD
role: STUDY_DIRECTOR
References: