Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
- Conditions
- Rapid Sequence Intubation
- Registration Number
- NCT06194058
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1150
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of a major haemodynamic disorder 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
- Secondary Outcome Measures
Name Time Method Clinical pre-anesthesic assessment of the risk of a full stomach 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
Pre-anesthetic assessment of the risk of a full stomach From 6 hours before induction of anesthesia until the beginning of the preoxygenation for the rapid sequence induction procedure - percentage of gastric ultrasound use
Team involved in the rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - average number of individuals in the room participating in the performance of SRI
Preparation for rapide sequence induction technique Within the first 10 minutes after induction of anesthesia - Percentage of patients in supine position
Use of morphine for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage of use of morphine derivative prior to airway securisation
Induction therapeutics for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage of use of each of the following hypnotics: propofol, ketamine, thiopental, etomidate, midazolam, sevoflurane
Assessment of the risk of a full stomach 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
Use of curare for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage of use of a curare
Use of vasopressive amine for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage and median dosage of vasopressive amine use for the prevention of low blood pressure
Use of filling solution for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage and median volume of use of a preventive vascular filling solution
Airway management for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - type of preoxygenation
Operator qualification for rapid sequence induction technique 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
Laryngoscopy for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage of use of a video laryngoscope as a 1st intention
Cardiac complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - cardiac arrest
Intubation complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of intubations that required more than one laryngoscopy
Medical device used for rapid sequence induction technique Within the first 10 minutes after induction of anesthesia - percentage of mandrel use at the first laryngoscopy
MBP complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of episode of MBP ≤ at 50 mmHg (or ≤ 40% of the baseline)
Low tension-related complications of ISR (< 10 minutes) 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)
Tension complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of episode of MBP ≥ 110 mmHg
Rythmal complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - sustained arrhythmia (\> 1 minute) not present at induction
High tension-related complications of ISR (< 10 minutes) 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)
Respiratory complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of respiratory complication defined by Spo2 \< 90% or the need for manual reventilation
Anaphylactic complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of Grade I, II, III or IV anaphylactic reaction
Inhalation complications of ISR (< 10 minutes) 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
Immediate complications of ISR (< 10 minutes) Within the first 10 minutes after induction of anesthesia - percentage of intraoperative deaths
Trial Locations
- Locations (30)
Clinique Victor Pauchet
🇫🇷Amiens, France
Hospital
🇫🇷Valenciennes, France
Hôpital Privé Arras les Bonnettes
🇫🇷Arras, France
University Hospital
🇫🇷Poitiers, France
Centre Hospitalier Intercommunal
🇫🇷Castres, France
Centre Léon Bérard
🇫🇷Lyon, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
Clinique de la Sauvegarde
🇫🇷Lyon, France
Saint Joseph Saint Luc Hospital
🇫🇷Lyon, France
University Hospital - Pasteur
🇫🇷Nice, France
University Hopital - Edouard Herriot
🇫🇷Lyon, France
Bichat Hospital - APHP
🇫🇷Paris, France
University Hospital - Sud
🇫🇷Lyon, 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
Clinique de la Sagesse
🇫🇷Rennes, France
University Hospital La Réunion - Site Nord
🇫🇷Saint-Denis, France
Yves Le Foll Hospital
🇫🇷Saint brieuc, 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
Hôpitaux du Leman
🇫🇷Thonon-les-Bains, France
University Hospital - Hautepierre
🇫🇷Strasbourg, France
Centre hospitalier intercommunal
🇫🇷Toulon, France
Clinique de Villeneuve Saint Georges
🇫🇷Villeneuve-Saint-Georges, France
Institut Gustave Roussy
🇫🇷Villejuif, France
University Hospital - Rangueil
🇫🇷Toulouse, France