Optimisation Strategy for Emergency Tracheal Intubation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Data patient
  Medical History and characteristic of patient
• Другое Physical examination
  Arterial pressure, arterial oxygen saturation, heart rate
• Процедура Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
  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.
• Процедура Rapid sequence intubation (RSI) : Recommendations for emergency 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.

Первичные конечные точки

• Severe intubation-related complications occurring during the first hour after intubation [Срок оценки: Day 0]

Вторичные конечные точки (10)

• Difficulty of the intubation process - Intubation Difficulty [Срок оценки: Day 0]
• Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen [Срок оценки: Day 0]
• Difficulty of the intubation process - Alternative techniques. [Срок оценки: Day 0]
• Difficulty of the intubation process - Intubation attempts [Срок оценки: Day 0]
• Difficulty of the intubation process - Intubation failures under direct laryngoscopy. [Срок оценки: Day 0]
• Out-of hospital care -Time of out-of-hospital care [Срок оценки: Day 0]
• Out-of hospital care - sedative drugs [Срок оценки: Day 0]
• Out-of hospital care - vasopressors [Срок оценки: Day 0]
• Out-of hospital care : Mortality [Срок оценки: Day 0]
• Mortality [Срок оценки: Day 28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 22 центра

• CHU d'Angers — Angers
• CH Carnelle Portes de l'Oise — Beaumont-sur-Oise
• AP-HP - Hôpital Avicenne — Bobigny
• CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
• CH de Pontoise René Dubos — Cergy-Pontoise
• AP-HP - Hôpital Henri Mondor — Créteil
• CHU de Dijon — Dijon
• GH Eaubonne Montmorency Hôpital Simone VEIL — Eaubonne
• … и ещё 14 центров

Идентификаторы

NCT: NCT05539391 · CHUBX 2021/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗