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

Rapid Sequence Intubation Clinical Trial

— CoC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194058
• Other study ID #: AR_2023_001
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Hugo Ingles, MD
• Phone: +33.2.40.08.73.80
• Email: hugo.ingles[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: May 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rapid Sequence Intubation

Intervention

Other:
• rapid 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

Country	Name	City	State
France	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	Hospital	Saint-Malo
France	University Hospital La Réunion - site Ouest	Saint-Paul
France	Groupe Hospitalier Seclin Carvin	Seclin
France	Centre Clinical - Angoulême	Soyaux
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

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a major haemodynamic disorder	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	Clinical pre-anesthesic assessment of the risk of a full stomach	- 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
Secondary	Pre-anesthetic assessment of the risk of a full stomach	- percentage of gastric ultrasound use	From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure
Secondary	Assessment of the risk of a full stomach	- 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
Secondary	Team involved in the rapid sequence induction technique	- average number of individuals in the room participating in the performance of SRI	Within the first 10 minutes after induction of anesthesia
Secondary	Preparation for rapide sequence induction technique	- Percentage of patients in supine position	Within the first 10 minutes after induction of anesthesia
Secondary	Use of morphine for rapid sequence induction technique	- percentage of use of morphine derivative prior to airway securisation	Within the first 10 minutes after induction of anesthesia
Secondary	Induction therapeutics for rapid sequence induction technique	- percentage of use of each of the following hypnotics: propofol, ketamine, thiopental, etomidate, midazolam, sevoflurane	Within the first 10 minutes after induction of anesthesia
Secondary	Use of curare for rapid sequence induction technique	- percentage of use of a curare	Within the first 10 minutes after induction of anesthesia
Secondary	Use of vasopressive amine for rapid sequence induction technique	- percentage and median dosage of vasopressive amine use for the prevention of low blood pressure	Within the first 10 minutes after induction of anesthesia
Secondary	Use of filling solution for rapid sequence induction technique	- percentage and median volume of use of a preventive vascular filling solution	Within the first 10 minutes after induction of anesthesia
Secondary	Airway management for rapid sequence induction technique	- type of preoxygenation	Within the first 10 minutes after induction of anesthesia
Secondary	Operator qualification for rapid sequence induction technique	- 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
Secondary	Laryngoscopy for rapid sequence induction technique	- percentage of use of a video laryngoscope as a 1st intention	Within the first 10 minutes after induction of anesthesia
Secondary	Medical device used for rapid sequence induction technique	- percentage of mandrel use at the first laryngoscopy	Within the first 10 minutes after induction of anesthesia
Secondary	MBP complications of ISR (< 10 minutes)	- percentage of episode of MBP = at 50 mmHg (or = 40% of the baseline)	Within the first 10 minutes after induction of anesthesia
Secondary	Tension complications of ISR (< 10 minutes)	- percentage of episode of MBP = 110 mmHg	Within the first 10 minutes after induction of anesthesia
Secondary	Rythmal complications of ISR (< 10 minutes)	- sustained arrhythmia (> 1 minute) not present at induction	Within the first 10 minutes after induction of anesthesia
Secondary	Cardiac complications of ISR (< 10 minutes)	- cardiac arrest	Within the first 10 minutes after induction of anesthesia
Secondary	Intubation complications of ISR (< 10 minutes)	- percentage of intubations that required more than one laryngoscopy	Within the first 10 minutes after induction of anesthesia
Secondary	Low tension-related complications of ISR (< 10 minutes)	- 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
Secondary	High tension-related complications of ISR (< 10 minutes)	- 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
Secondary	Respiratory complications of ISR (< 10 minutes)	- percentage of respiratory complication defined by Spo2 < 90% or the need for manual reventilation	Within the first 10 minutes after induction of anesthesia
Secondary	Anaphylactic complications of ISR (< 10 minutes)	- percentage of Grade I, II, III or IV anaphylactic reaction	Within the first 10 minutes after induction of anesthesia
Secondary	Inhalation complications of ISR (< 10 minutes)	- 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
Secondary	Immediate complications of ISR (< 10 minutes)	- percentage of intraoperative deaths	Within the first 10 minutes after induction of anesthesia