Optimisation Strategy for Emergency Tracheal Intubation

NCT05539391 | Recruiting

• 1 other identifier: CHUBX 2021/25
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 22

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.

Conditions

Emergencies; Out-of-hospital Setting; Tracheal Intubation

Keywords

Out-of-hospital; Intubation; Complications; Vital distress; Rapid sequence intubation; Rocuronium; Gum Elastic Bougie

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 - Alternative techniques.

  Day 0

• Difficulty of the intubation process - Intubation attempts

  Day 0

• Difficulty of the intubation process - Intubation failures under direct laryngoscopy.

  Day 0

Study Arms (2)

Treatment group

EXPERIMENTAL

Combination rapid sequence intubation (RSI) with use of rocuronium and the bag-mask ventilation between induction and Gum Elastic Bougie GEB will be systematically used at the first attempt to facilitate intubation.

Other: Data patient; Other: Physical examination; Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB

Control Group

ACTIVE COMPARATOR

Physicians will be reminded of the current recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine and use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.

Other: Data patient; Other: Physical examination; Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation

Interventions

Data patient OTHER

Medical History and characteristic of patient

Control Group; Treatment group

Physical examination OTHER

Arterial pressure, arterial oxygen saturation, heart rate

Control Group; Treatment group

Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB PROCEDURE

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.

Treatment group

Rapid sequence intubation (RSI) : Recommendations for emergency intubation PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (22)

CHU d'Angers

Angers, 49933, France

RECRUITING

CH Carnelle Portes de l'Oise

Beaumont-sur-Oise, 95260, France

RECRUITING

AP-HP - Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CH de Pontoise René Dubos

Cergy-Pontoise, 95303, France

RECRUITING

AP-HP - Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

CHU de Dijon

Dijon, 21000, France

NOT YET RECRUITING

GH Eaubonne Montmorency Hôpital Simone VEIL

Eaubonne, 95600, France

RECRUITING

AP-HP - Hôpital Raymond Poincaré

Garches, 92380, France

RECRUITING

CHU de Grenoble - Hôpital Nord La Tronche

La Tronche, 38700, France

RECRUITING

CH de Versailles - Site André Mignot

Le Chesnay, 78157, France

NOT YET RECRUITING

HCL - Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

GH Sud Ile de France

Melun, 77000, France

RECRUITING

CHU de Montpellier Site Lapeyronie

Montpellier, 34000, France

RECRUITING

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, 44093, France

RECRUITING

AP-HP - Hôpital Lariboisière

Paris, 75013, France

RECRUITING

AP-HP - Hôpital Pitié-Salpétrière

Paris, 75013, France

RECRUITING

AP-HP - Hôpital Necker

Paris, 75730, France

RECRUITING

CHU Poitiers - Hôpital la Milétrie

Poitiers, 86021, France

RECRUITING

CHU de la Réunion - site Sud

Saint-Pierre, 97448, France

RECRUITING

GH Sélestat Obernai

Sélestat, 67 600, France

NOT YET RECRUITING

CHU Toulouse - Hôpital Purpan

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Restraint, Physical; Rapid Sequence Induction and Intubation; Rocuronium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Intubation, Intratracheal; Airway Management; Intubation; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xavier COMBES, Pr

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier COMBES, Pr

CONTACT

05 56 79 49 47; xavier.combes@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: September 14, 2022
• Study Start: January 14, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)