Optimisation Strategy for Emergency Tracheal Intubation

Not Applicable

Recruiting

• Conditions: Emergencies; Out-of-hospital Setting; Tracheal Intubation

• Registration Number: NCT05539391
• Lead Sponsor: University Hospital, Bordeaux

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 Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Study Start: 2023-01-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severe intubation-related complications occurring during the first hour after intubation	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 Outcome Measures

Name	Time	Method
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.	Day 0	Mean number of intubation failures under direct laryngoscopy.
Difficulty of the intubation process - Alternative techniques.	Day 0	Proportion of patients intubated by alternative techniques.
Out-of hospital care : Mortality	Day 0	Out-of-hospital mortality.
Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen	Day 0	Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable
Difficulty of the intubation process - Intubation attempts	Day 0	Mean number of intubation attempts
Out-of hospital care -Time of out-of-hospital care	Day 0	Mean time of out-of-hospital care (in minutes)
Out-of hospital care - vasopressors	Day 0	Mean total amount of vasopressors used after intubation
Out-of hospital care - sedative drugs	Day 0	Mean total amount of sedative drugs used after intubation
Mortality	Day 28	Vital status
Difficulty of the intubation process - Intubation Difficulty	Day 0	Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.

Trial Locations

Locations (19)

CHU d'Angers; 🇫🇷 Angers, France

CH Carnelle Portes de l'Oise; 🇫🇷 Beaumont-sur-Oise, France

AP-HP - Hôpital Avicenne; 🇫🇷 Bobigny, France

CHU de Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

CH de Pontoise René Dubos; 🇫🇷 Cergy-Pontoise, France

AP-HP - Hôpital Henri Mondor; 🇫🇷 Créteil, France

GH Eaubonne Montmorency Hôpital Simone VEIL; 🇫🇷 Eaubonne, France

AP-HP - Hôpital Raymond Poincaré; 🇫🇷 Garches, France

CHU de Grenoble - Hôpital Nord La Tronche; 🇫🇷 La Tronche, France

HCL - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

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