Optimisation Strategy for Emergency Tracheal Intubation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial

Conditions
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Emergencies, Out-of-hospital Setting, Tracheal Intubation

Intervention / Treatment
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* Other: Data patient
* Other: Physical examination
* Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
* Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* Medical History and characteristic of patient<br>Other: Physical examination<br>* Arterial pressure, arterial oxygen saturation, heart rate<br>Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB<br>* 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.<br>|
| Active Comparator: Control Group<br>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<br>* Medical History and characteristic of patient<br>Other: Physical examination<br>* Arterial pressure, arterial oxygen saturation, heart rate<br>Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Day 0 | 
| Difficulty of the intubation process - Alternative techniques. | Proportion of patients intubated by alternative techniques. | Day 0 | 
| Difficulty of the intubation process - Intubation attempts | Mean number of intubation attempts | Day 0 | 
| Difficulty of the intubation process - Intubation failures under direct laryngoscopy. | Mean number of intubation failures under direct laryngoscopy. | Day 0 | 
| Out-of hospital care -Time of out-of-hospital care | Mean time of out-of-hospital care (in minutes) | Day 0 | 
| Out-of hospital care - sedative drugs | Mean total amount of sedative drugs used after intubation | Day 0 | 
| Out-of hospital care - vasopressors | Mean total amount of vasopressors used after intubation | Day 0 | 
| Out-of hospital care : Mortality | Out-of-hospital mortality. | Day 0 | 
| Mortality | Vital status | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation, Rocuronium, Gum Elastic Bougie