Rapid Sequence IntubationCoCNCT06194058
Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
An observational study of Rapid Sequence Intubation, run by Nantes University Hospital at 42 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Sequence Intubation
- What is being tested?
- rapid sequence anesthetic induction
- How many people
- 1,150 participants
- Where
- 42 sitesFrance
- Study dates
- 15 Nov 2023to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
France42 sites, 42 recruiting
- Recruiting
Clinique Victor Pauchet
Amiens
Pierre Huette
- Recruiting
Hospital
Arcachon
Jeremy Allary, Jeremy.Allary@ch-arcachon.fr
- Recruiting
Hospital
Armentières
Lucile Debaecker, l.debaecker@ch-armentieres.fr
- Recruiting
Hôpital Privé Arras les Bonnettes
Arras
Matthias Garrot
- Recruiting
University Hospital
Brest
Anais Caillard
- Recruiting
University Hospital
Caen
Valentin Lefrancois, lefrancois-v@chu-caen.fr
- Recruiting
Centre Hospitalier Intercommunal
Castres
Mathilde Vernet, mathilde.vernet@chic-cm.fr
- Recruiting
University Hospital
Clermont-Ferrand
Thomas Godet, tgodet@chu-clermontferrand.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Mathieu Oudot
- Not yet recruiting
University Hospital
Lille
Victor Lestrade
- Recruiting
Hospital
Lorient
Seamus Thierry, s.thierry@ghbs.bzh
- Recruiting
Centre Léon Bérard
Lyon
Grégoire Wallon
- Recruiting
Clinique de la Sauvegarde
Lyon
Olivier Desebbe
- Recruiting
Saint Joseph Saint Luc Hospital
Lyon
Mathieu Fontaine, mfontaine@saintjosephsaintluc.fr
- Recruiting
University Hopital - Edouard Herriot
Lyon
Emma Aka, emma.aka@chu-lyon.fr
- Recruiting
University Hospital - Sud
Lyon
Marc Bouchet, marc.bouchet@chu-lyon.fr
- Not yet recruiting
Hospital
Mont-de-Marsan
Andersen Ramorasata, andersen.ramorasata@ch-mdm.fr
- Recruiting
Hospital
Montargis
Ahiab Alnumier, aalnumier@ch-montargis.fr
- Recruiting
University Hospital
Nantes
Hugo Ingles
- Recruiting
University Hospital - Pasteur
Nice
Victor Gridel, gridel.v@chu-nice.fr
- Recruiting
Bichat Hospital - APHP
Paris
Aurélie Gouel, aurelie.gouel@aphp.fr
- Recruiting
Hopital Lariboisiere - APHP
Paris
Sophie Dagois, sophie.dagois@aphp.fr
- Recruiting
Hopital Pitié Salpetriere - APHP
Paris
Dimitri Margetis, dimitri.margetis@aphp.fr
- Recruiting
Hopital Saint Louis, Lariboisiere, Fernand Widal - APHP
Paris
Anouare Friaa, anouare.friaa@aphp.fr
- Recruiting
Hôpital Tenon - APHP
Paris
Gauthier Hamon
- Not yet recruiting
University Hospital
Poitiers
Quentin Saint Genis, Quentin.SAINT-GENIS@chu-poitiers.fr
- Recruiting
Clinique de la Sagesse
Rennes
Stéphanie Chevalier, stephanie.chevalier@hospigrandouest.fr
- Recruiting
Hospital
Rodez
Julie Delmas, J.DELMAS@ch-rodez.fr
- Not yet recruiting
Yves Le Foll Hospital
Saint-Brieuc
Lauren Daviet, lauren.daviet@armorsante.bzh
- Recruiting
University Hospital La Réunion - Site Nord
Saint-Denis
Laurent Thiltges, laurent.thiltges@chu-reunion.fr
- Recruiting
University Hospital La Réunion - site Ouest
Saint-Paul
Alexis Carpentier, Al.CARPENTIER@chor.re
- Not yet recruiting
Groupe Hospitalier Seclin Carvin
Seclin
Alexandre Turbelin, alexandre.turbelin@ghsc.fr
- Recruiting
Centre Clinical - Angoulême
Soyaux
Gianluca Caragliano
- Recruiting
Hospital
St-Malo
Guillaume Allo, G.ALLO@ch-stmalo.fr
- Recruiting
Clinique Rhéna
Strasbourg
Nadège Erb
- Recruiting
University Hospital - Hautepierre
Strasbourg
Julie Gaudefroy, julie.gaudefroy@chru-strasbourg.fr
- Recruiting
Hôpitaux du Leman
Thonon-les-Bains
Caroline Gauthier, C-GAUTHIER@ch-hopitauxduleman.fr
- Recruiting
Centre hospitalier intercommunal
Toulon
Sophie Prieur, SOPHIE.PRIEUR@ch-toulon.fr
- Not yet recruiting
University Hospital - Rangueil
Toulouse
Vincent Pey, pey.vi@chu-toulouse.fr
- Recruiting
Hospital
Valenciennes
Fanny Cointre
- Not yet recruiting
Institut Gustave Roussy
Villejuif
Jamie Elmawieh, Jamie.ELMAWIEH@gustaveroussy.fr
- Not yet recruiting
Clinique de Villeneuve Saint Georges
Villeneuve-Saint-Georges
Virginie Trehel-Tursis
About this study
Official title: 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.
Read more
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
- Rapid Sequence Intubation
- Being tested
- rapid sequence anesthetic induction
- Keywords
- anesthetic induction, adult patients, hemodynamic disorders, arrythmia, cardiac arrest, pre-oxygenation, mean blood pressure
- Medical subject headings
- Arrhythmias, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid sequence anesthetic inductionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first 10 minutes after induction of anesthesia
Secondary outcomes (25)
Clinical pre-anesthesic assessment of the risk of a full stomach
- percentage of clinical and/or imaging endpoints in favor of a full stomach
Measured: 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
- percentage of gastric ultrasound use
Measured: 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
- percentage of presence and use of the Nasogastric Tube
Measured: 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
- average number of individuals in the room participating in the performance of SRI
Measured: Within the first 10 minutes after induction of anesthesia
Preparation for rapide sequence induction technique
- Percentage of patients in supine position
Measured: Within the first 10 minutes after induction of anesthesia
Use of morphine for rapid sequence induction technique
- percentage of use of morphine derivative prior to airway securisation
Measured: Within the first 10 minutes after induction of anesthesia
Induction therapeutics for rapid sequence induction technique
- percentage of use of each of the following hypnotics: propofol, ketamine, thiopental, etomidate, midazolam, sevoflurane
Measured: Within the first 10 minutes after induction of anesthesia
Use of curare for rapid sequence induction technique
- percentage of use of a curare
Measured: Within the first 10 minutes after induction of anesthesia
Use of vasopressive amine for rapid sequence induction technique
- percentage and median dosage of vasopressive amine use for the prevention of low blood pressure
Measured: Within the first 10 minutes after induction of anesthesia
Use of filling solution for rapid sequence induction technique
- percentage and median volume of use of a preventive vascular filling solution
Measured: Within the first 10 minutes after induction of anesthesia
Airway management for rapid sequence induction technique
- type of preoxygenation
Measured: Within the first 10 minutes after induction of anesthesia
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
Measured: Within the first 10 minutes after induction of anesthesia
Laryngoscopy for rapid sequence induction technique
- percentage of use of a video laryngoscope as a 1st intention
Measured: Within the first 10 minutes after induction of anesthesia
Medical device used for rapid sequence induction technique
- percentage of mandrel use at the first laryngoscopy
Measured: Within the first 10 minutes after induction of anesthesia
MBP complications of ISR (< 10 minutes)
- percentage of episode of MBP ≤ at 50 mmHg (or ≤ 40% of the baseline)
Measured: Within the first 10 minutes after induction of anesthesia
Tension complications of ISR (< 10 minutes)
- percentage of episode of MBP ≥ 110 mmHg
Measured: Within the first 10 minutes after induction of anesthesia
Rythmal complications of ISR (< 10 minutes)
- sustained arrhythmia (> 1 minute) not present at induction
Measured: Within the first 10 minutes after induction of anesthesia
Cardiac complications of ISR (< 10 minutes)
- cardiac arrest
Measured: Within the first 10 minutes after induction of anesthesia
Intubation complications of ISR (< 10 minutes)
- percentage of intubations that required more than one laryngoscopy
Measured: Within the first 10 minutes after induction of anesthesia
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)
Measured: Within the first 10 minutes after induction of anesthesia
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)
Measured: Within the first 10 minutes after induction of anesthesia
Respiratory complications of ISR (< 10 minutes)
- percentage of respiratory complication defined by Spo2 < 90% or the need for manual reventilation
Measured: Within the first 10 minutes after induction of anesthesia
Anaphylactic complications of ISR (< 10 minutes)
- percentage of Grade I, II, III or IV anaphylactic reaction
Measured: Within the first 10 minutes after induction of anesthesia
Inhalation complications of ISR (< 10 minutes)
- percentage of gastric fluid inhalation defined by the presence of non-salivary fluid or supraglottic solids during laryngoscopy
Measured: Within the first 10 minutes after induction of anesthesia
Immediate complications of ISR (< 10 minutes)
- percentage of intraoperative deaths
Measured: Within the first 10 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Responsible party
- Sponsor
- Investigators
- Nicolas Grillot, MD, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194058
- Sponsor's protocol ID
- AR_2023_001
- Acronym
- CoC
- Status last verified
- May 2024
- First submitted
- 14 Nov 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study. The Crush or Crash Study.
- ClinicalTrials.gov ID
- NCT06194058
- Acronym / sponsor ID
- CoC / AR_2023_001
- Conditions
- Rapid Sequence Intubation
- Keywords
- anesthetic induction, adult patients, hemodynamic disorders, arrythmia, cardiac arrest, pre-oxygenation, mean blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid 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. | Other | – |
Primary outcome
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
25 secondary outcomes
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
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
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
Team involved in the rapid sequence induction technique
Time frame: 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
Use of morphine for rapid sequence induction technique
Time frame: 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
Use of curare for rapid sequence induction technique
Time frame: 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
Use of filling solution for rapid sequence induction technique
Time frame: 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
Operator qualification for rapid sequence induction technique
Time frame: 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
Medical device used for rapid sequence induction technique
Time frame: 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
Tension complications of ISR (< 10 minutes)
Time frame: 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
Cardiac complications of ISR (< 10 minutes)
Time frame: 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
Low tension-related complications of ISR (< 10 minutes)
Time frame: 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
Respiratory complications of ISR (< 10 minutes)
Time frame: 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
Inhalation complications of ISR (< 10 minutes)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Rapid Sequence Intubation
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
Recruiting
Comparison of Peri-intubation Oxygenation Values and Complications in Patients Intubated With the Delayed Versus Rapid Sequence Intubation Protocols
Delayed Sequence Intubation, Rapid Sequence Induction and Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Grillot, MD study director
Nantes University Hospital
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Sequence Intubation, run by Nantes University Hospital at 42 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugo Ingles, MD (+33.2.40.08.73.80, hugo.ingles@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a major haemodynamic disorder (time frame: Within the first 10 minutes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.