Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,500
- Locations
- 44
- Primary Endpoint
- Severe intubation-related complications occurring during the first hour after intubation
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Difficulty of the intubation process - Intubation failures under direct laryngoscopy.(Day 0)
- Difficulty of the intubation process - Alternative techniques.(Day 0)
- Out-of hospital care : Mortality(Day 0)
- Mortality(Day 28)
- Difficulty of the intubation process - Intubation Difficulty(Day 0)
- Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen(Day 0)
- Difficulty of the intubation process - Intubation attempts(Day 0)
- Out-of hospital care -Time of out-of-hospital care(Day 0)
- Out-of hospital care - vasopressors(Day 0)
- Out-of hospital care - sedative drugs(Day 0)