Optimisation Strategy for Emergency Tracheal Intubation

Emergencies Clinical Trial

— OSETIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539391
• Other study ID #: CHUBX 2021/25
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Bordeaux
• Contact: Xavier COMBES, Pr
• Phone: 05 56 79 49 47
• Email: xavier.combes[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Tracheal Intubation

Intervention

Other:
• Data patient
Medical History and characteristic of patient
• Physical examination
Arterial pressure, arterial oxygen saturation, heart rate

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
France	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	GH Sud Ile de France	Melun
France	CHU de Montpellier Site Lapeyronie	Montpellier
France	CHU de Nantes - Hôpital Hôtel Dieu	Nantes
France	AP-HP - Hôpital Lariboisière	Paris
France	AP-HP - Hôpital Necker	Paris
France	AP-HP - Hôpital Pitié-Salpétrière	Paris
France	CHU Poitiers - Hôpital la Milétrie	Poitiers
France	CHU de la Réunion - Hôpital Felix Guyon	Saint-Denis
France	CHU de la Réunion - site Sud	Saint-Pierre
France	CHU Toulouse - Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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