An interventional study of Data patient and Physical examination in Emergencies, Out-of-hospital Setting and Tracheal Intubation, sponsored by University Hospital, Bordeaux. Recruiting at 22 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Data patient · Other: Physical examination · Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
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.
Other: Data patient · Other: Physical examination · Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation
Medical History and characteristic of patient
Arterial pressure, arterial oxygen saturation, heart rate
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) 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.
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.
Time frame: Day 0
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.
Time frame: 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
Time frame: Day 0
Difficulty of the intubation process - Alternative techniques.
Proportion of patients intubated by alternative techniques.
Time frame: Day 0
Difficulty of the intubation process - Intubation attempts
Mean number of intubation attempts
Time frame: Day 0
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Mean number of intubation failures under direct laryngoscopy.
Time frame: Day 0
Out-of hospital care -Time of out-of-hospital care
Mean time of out-of-hospital care (in minutes)
Time frame: Day 0
Out-of hospital care - sedative drugs
Mean total amount of sedative drugs used after intubation
Time frame: Day 0
Out-of hospital care - vasopressors
Mean total amount of vasopressors used after intubation
Time frame: Day 0
Out-of hospital care : Mortality
Out-of-hospital mortality.
Time frame: Day 0
Mortality
Vital status
Time frame: Day 28
Plan to share: No
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University Hospital, Bordeaux