EmergenciesOSETIMNCT05539391
Optimisation Strategy for Emergency Tracheal Intubation
A study testing Data patient, Physical examination and Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB in people with Emergencies and Out-of-hospital Setting, run by University Hospital, Bordeaux at 22 sites in France.
Trial summary
This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Out-of-hospital Setting, Tracheal Intubation
- What is being tested?
- Data patient, Physical examination and Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 22 sitesFrance
- Study dates
- 14 Jan 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient adult (≥ 18 years) presenting with vital distress requiring emergency tracheal intubation as assessed by the emergency physician in the out-of-hospital setting.
- Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest will be included.
Who cannot join
- Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist).
- Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis).
- Patient that are not members of a medical aid scheme (beneficiary or main member).
- Patient under specific protection measures: pregnant, parturient or nursing women; legal protection or deprived of liberty: patient under judicial protection, patient under guardianship/curatorship.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
France22 sites, 22 recruiting
- Recruiting
CHU d'Angers
Angers, 49933
Dominique SAVARY, dominique.savary@chu-angers.fr
- Recruiting
CH Carnelle Portes de l'Oise
Beaumont-sur-Oise, 95260
Agnès Agnès RICARD-HIBON, agnes.ricard-hibon@ght-novo.fr
- Recruiting
AP-HP - Hôpital Avicenne
Bobigny, 93000
Frédéric LAPOSTOLLE, frederic.lapostolle@aphp.fr
- Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Xavier COMBES, Pr, xavier.combes@chu-bordeaux.fr
Xavier COMBES, PR
- Recruiting
CH de Pontoise René Dubos
Cergy-Pontoise, 95303
Agnès RICARD-HIBON, agnes.ricard-hibon@ght-novo.fr
- Recruiting
AP-HP - Hôpital Henri Mondor
Créteil, 94000
Charlotte CHOLLET-XEMARD, charlotte.chollet@aphp.fr
- Not yet recruiting
CHU de Dijon
Dijon, 21000
Patrick RAY, patrick.ray@chu-dijon.fr
- Recruiting
GH Eaubonne Montmorency Hôpital Simone VEIL
Eaubonne, 95600
Laure GUILLOUX, laure.guilloux@hotmail.fr
- Recruiting
AP-HP - Hôpital Raymond Poincaré
Garches, 92380
Armelle SEVERIN, armelle.severin@aphp.fr
- Recruiting
CHU de Grenoble - Hôpital Nord La Tronche
La Tronche, 38700
Guillaume DEBATY, gdebaty@chu-grenoble.fr
- Not yet recruiting
CH de Versailles - Site André Mignot
Le Chesnay, 78157
Clotilde CAZENAVE, ccazenave@ght78sud.fr
- Recruiting
HCL - Hôpital Edouard Herriot
Lyon, 69003
Marine PAUPE, marine.paupe@chu-lyon.fr
- Recruiting
GH Sud Ile de France
Melun, 77000
Yousra GUETARI, yousra.guetari@ghsif.fr
- Recruiting
CHU de Montpellier Site Lapeyronie
Montpellier, 34000
Xavier BOBBIA, xavier.bobbia@chu-montpellier.fr
- Recruiting
CHU de Nantes - Hôpital Hôtel Dieu
Nantes, 44093
Quentin LE BASTARD, quentin.lebastard@chu-nantes.fr
- Recruiting
AP-HP - Hôpital Lariboisière
Paris, 75013
Xavier EYER, xavier.eyer@aphp.fr
- Recruiting
AP-HP - Hôpital Pitié-Salpétrière
Paris, 75013
Patrick ECOLLAN, patrick.ecollan@aphp.fr
- Recruiting
AP-HP - Hôpital Necker
Paris, 75730
Thomas NICOL, thomas.nicol@aphp.fr
- Recruiting
CHU Poitiers - Hôpital la Milétrie
Poitiers, 86021
Nicolas MARJANOVIC, nicolas.marjanovic@chu-poitiers.fr
- Recruiting
CHU de la Réunion - site Sud
Saint-Pierre, 97448
Adrien MARTEAU, adrien.marteau@chu-reunion.fr
- Not yet recruiting
GH Sélestat Obernai
Sélestat, 67 600
Gautier DROMSON, gautier.dromson@ghso.fr
- Recruiting
CHU Toulouse - Hôpital Purpan
Toulouse, 31059
Bertrand GUIHARD, guihard.b@chu-toulouse.fr
About this study
Official title: Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.
Read the detailed description
Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.
- Conditions
- Emergencies, Out-of-hospital Setting, Tracheal Intubation
- Being tested
- Data patient, Physical examination, Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB, Rapid sequence intubation (RSI) : Recommendations for emergency intubation
- Keywords
- Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation, Rocuronium, Gum Elastic Bougie
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data patientOther
Medical History and characteristic of patient
Physical examinationOther
Arterial pressure, arterial oxygen saturation, heart rate
Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEBProcedure or surgery
Rapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation.
Rapid sequence intubation (RSI) : Recommendations for emergency intubationProcedure or surgery
Rapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Combination rapid sequence intubation (RSI) with use of rocuronium and the bag-mask ventilation between induction and Gum Elastic Bougie GEB will be systematically used at the first attempt to facilitate intubation. Receives: Other: Data patient; Other: Physical examination; Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB |
| Control Group | Active comparator | Physicians will be reminded of the current recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine and use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy. Receives: Other: Data patient; Other: Physical examination; Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe intubation-related complications occurring during the first hour after intubation
Proportion of patients with severe intubation-related complications occurring during the first hour after intubation
The severe intubation-related complications are:
- Cardiac arrest.
- At least one arterial hypotension episode defined by systolic blood pressure<90 mmHg.
- At least one hypoxemia episode defined by an occurrence of a new episode of oxygen.
- Saturation < 90%.
- Severe cardiac arrhythmia: ventricular tachycardia.
- Pulmonary aspiration, reported by the physician.
- Esophageal intubation.
- Unintentional extubation. Severe intubation-related complications will be recorded by the emergency physician in charge of the patient.
Measured: Day 0
Secondary outcomes (10)
Difficulty of the intubation process - Intubation Difficulty
Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.
Measured: Day 0
Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen
Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable
Measured: Day 0
Difficulty of the intubation process - Alternative techniques.
Proportion of patients intubated by alternative techniques.
Measured: Day 0
Difficulty of the intubation process - Intubation attempts
Mean number of intubation attempts
Measured: Day 0
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Mean number of intubation failures under direct laryngoscopy.
Measured: Day 0
Out-of hospital care -Time of out-of-hospital care
Mean time of out-of-hospital care (in minutes)
Measured: Day 0
Out-of hospital care - sedative drugs
Mean total amount of sedative drugs used after intubation
Measured: Day 0
Out-of hospital care - vasopressors
Mean total amount of vasopressors used after intubation
Measured: Day 0
Out-of hospital care : Mortality
Out-of-hospital mortality.
Measured: Day 0
Mortality
Vital status
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start14 Jan 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier COMBES, Pr, Principal investigator, Université Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539391
- Sponsor's protocol ID
- CHUBX 2021/25
- Acronym
- OSETIM
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05539391
- Acronym / sponsor ID
- OSETIM / CHUBX 2021/25
- Conditions
- Emergencies, Out-of-hospital Setting, Tracheal Intubation
- Keywords
- Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation, Rocuronium, Gum Elastic Bougie
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Sep 2022 (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.
This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.
Detailed description
Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Data patient, Other: Physical examination, Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEBCombination rapid sequence intubation (RSI) with use of rocuronium and the bag-mask ventilation between induction and Gum Elastic Bougie GEB will be systematically used at the first attempt to facilitate intubation. |
| Control Group | Active comparator | Other: Data patient, Other: Physical examination, Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubationPhysicians will be reminded of the current recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine and use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient adult (≥ 18 years) presenting with vital distress requiring emergency tracheal intubation as assessed by the emergency physician in the out-of-hospital setting.
- Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest will be included.
Key exclusion criteria (4 listed)
- Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist).
- Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis).
- Patient that are not members of a medical aid scheme (beneficiary or main member).
- Patient under specific protection measures: pregnant, parturient or nursing women; legal protection or deprived of liberty: patient under judicial protection, patient under guardianship/curatorship.
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 |
|---|---|---|
| Data patientMedical History and characteristic of patient | Other | Control Group, Treatment group |
| Physical examinationArterial pressure, arterial oxygen saturation, heart rate | Other | Control Group, Treatment group |
| Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEBRapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation. | Procedure or surgery | Treatment group |
| Rapid sequence intubation (RSI) : Recommendations for emergency intubationRapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy. | Procedure or surgery | Control Group |
Primary outcome
Severe intubation-related complications occurring during the first hour after intubation
Time frame: Day 0
Proportion of patients with severe intubation-related complications occurring during the first hour after intubation The severe intubation-related complications are: * Cardiac arrest. * At least one arterial hypotension episode defined by systolic blood pressure<90 mmHg. * At least one hypoxemia episode defined by an occurrence of a new episode of oxygen. * Saturation < 90%. * Severe cardiac arrhythmia: ventricular tachycardia. * Pulmonary aspiration, reported by the physician. * Esophageal intubation. * Unintentional extubation. Severe intubation-related complications will be recorded by the emergency physician in charge of the patient.
10 secondary outcomes
Difficulty of the intubation process - Intubation Difficulty
Time frame: Day 0
Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen
Time frame: Day 0
Difficulty of the intubation process - Alternative techniques.
Time frame: Day 0
Difficulty of the intubation process - Intubation attempts
Time frame: Day 0
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Time frame: Day 0
Out-of hospital care -Time of out-of-hospital care
Time frame: Day 0
Out-of hospital care - sedative drugs
Time frame: Day 0
Out-of hospital care - vasopressors
Time frame: Day 0
Out-of hospital care : Mortality
Time frame: Day 0
Mortality
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Emergencies
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
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.
Xavier COMBES, Pr principal investigator
Université Hospital, Bordeaux
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data patient, Physical examination and Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB in people with Emergencies and Out-of-hospital Setting, run by University Hospital, Bordeaux at 22 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier COMBES, Pr (05 56 79 49 47 ext. 033, xavier.combes@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe intubation-related complications occurring during the first hour after intubation (time frame: Day 0). 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 24 Sep 2025.