Clinical trial NCT05539391: Optimisation Strategy for Emergency Tracheal Intubation
Official title: Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergencies
Out-of-hospital Setting
Tracheal Intubation
Keywords: Out-of-hospital
Intubation
Complications
Vital distress
Rapid sequence intubation
Rocuronium
Gum Elastic Bougie
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severe intubation-related complications occurring during the first hour after intubation
timeFrame: Day 0
Secondary outcomes:
measure: Difficulty of the intubation process - Intubation Difficulty
timeFrame: Day 0
measure: Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen
timeFrame: Day 0
measure: Difficulty of the intubation process - Alternative techniques.
timeFrame: Day 0
measure: Difficulty of the intubation process - Intubation attempts
timeFrame: Day 0
measure: Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
timeFrame: Day 0
measure: Out-of hospital care -Time of out-of-hospital care
timeFrame: Day 0
measure: Out-of hospital care - sedative drugs
timeFrame: Day 0
measure: Out-of hospital care - vasopressors
timeFrame: Day 0
measure: Out-of hospital care : Mortality
timeFrame: Day 0
measure: Mortality
timeFrame: Day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Beaumont-sur-Oise
country: France
facility: CH Carnelle Portes de l'Oise
city: Bobigny
country: France
facility: AP-HP - Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Cergy-Pontoise
country: France
facility: CH de Pontoise René Dubos
city: Créteil
country: France
facility: AP-HP - Hôpital Henri Mondor
city: Eaubonne
country: France
facility: GH Eaubonne Montmorency Hôpital Simone VEIL
city: Garches
country: France
facility: AP-HP - Hôpital Raymond Poincaré
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital Nord La Tronche
city: Lyon
country: France
facility: HCL - Hôpital Edouard Herriot
city: Melun
country: France
facility: GH Sud Ile de France
city: Montpellier
country: France
facility: CHU de Montpellier Site Lapeyronie
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Hôtel Dieu
city: Paris
country: France
facility: AP-HP - Hôpital Lariboisière
city: Paris
country: France
facility: AP-HP - Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: AP-HP - Hôpital Necker
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital la Milétrie
city: Saint-Pierre
country: France
facility: CHU de la Réunion - site Sud
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpan
Study officials:
affiliation: Université Hospital, Bordeaux
name: Xavier COMBES, Pr
role: PRINCIPAL_INVESTIGATOR
References: