Optimizing emergency tracheal intubation techniques
Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
NA · University Hospital, Bordeaux · NCT05539391
This study is testing a new way to make emergency tracheal intubation safer for adults in critical condition by using a combination of medications and techniques.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 22 sites (Angers and 21 other locations) |
| Trial ID | NCT05539391 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a combined strategy to reduce complications associated with emergency tracheal intubation in adults experiencing vital distress. The approach includes the systematic use of rocuronium as a paralytic agent, bag face-mask ventilation prior to intubation, and the use of a Gum Elastic Bougie (GEB) during the first intubation attempt. Previous studies have indicated that these individual interventions can lower the incidence of peri-intubation complications, but their combined effect has not been assessed. The outcomes will be recorded immediately after the out-of-hospital period and further data will be collected from medical records 28 days post-inclusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require emergency tracheal intubation due to vital distress, excluding those in cardiac arrest.
Not a fit: Patients with contraindications to the medications used or those unable to undergo bag face-mask ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this strategy could significantly reduce morbidity associated with emergency intubation procedures.
How similar studies have performed: While individual components of this strategy have shown success in previous studies, the combined approach has not been tested before.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Angers and 21 other locations
- CHU d'Angers — Angers, France (RECRUITING)
- CH Carnelle Portes de l'Oise — Beaumont-sur-Oise, France (RECRUITING)
- AP-HP - Hôpital Avicenne — Bobigny, France (RECRUITING)
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (RECRUITING)
- CH de Pontoise René Dubos — Cergy-Pontoise, France (RECRUITING)
- AP-HP - Hôpital Henri Mondor — Créteil, France (RECRUITING)
- CHU de Dijon — Dijon, France (NOT_YET_RECRUITING)
- GH Eaubonne Montmorency Hôpital Simone VEIL — Eaubonne, France (RECRUITING)
- AP-HP - Hôpital Raymond Poincaré — Garches, France (RECRUITING)
- CHU de Grenoble - Hôpital Nord La Tronche — La Tronche, France (RECRUITING)
- CH de Versailles - Site André Mignot — Le Chesnay, France (NOT_YET_RECRUITING)
- HCL - Hôpital Edouard Herriot — Lyon, France (RECRUITING)
- GH Sud Ile de France — Melun, France (RECRUITING)
- CHU de Montpellier Site Lapeyronie — Montpellier, France (RECRUITING)
- CHU de Nantes - Hôpital Hôtel Dieu — Nantes, France (RECRUITING)
- AP-HP - Hôpital Lariboisière — Paris, France (RECRUITING)
- AP-HP - Hôpital Pitié-Salpétrière — Paris, France (RECRUITING)
- AP-HP - Hôpital Necker — Paris, France (RECRUITING)
- CHU Poitiers - Hôpital la Milétrie — Poitiers, France (RECRUITING)
- CHU de la Réunion - site Sud — Saint-Pierre, France (RECRUITING)
- GH Sélestat Obernai — Sélestat, France (NOT_YET_RECRUITING)
- CHU Toulouse - Hôpital Purpan — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Xavier COMBES, Pr — Université Hospital, Bordeaux
- Study coordinator: Xavier COMBES, Pr
- Email: xavier.combes@chu-bordeaux.fr
- Phone: 05 56 79 49 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Emergencies, Out-of-hospital Setting, Tracheal Intubation, Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation