Optimisation Strategy for Emergency Tracheal Intubation
- Conditions
- EmergenciesOut-of-hospital SettingTracheal Intubation
- Interventions
- Other: Data patientOther: Physical examination
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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
- Arm && Interventions
Group Intervention Description Control Group Data patient 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. Treatment group Data patient 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. Control Group Physical examination 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. Treatment group Physical examination 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.
- 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.
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.
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
Trial Locations
- Locations (19)
CHU de la Réunion - site Sud
🇫🇷Saint-Pierre, France
CH Carnelle Portes de l'Oise
🇫🇷Beaumont-sur-Oise, France
CHU d'Angers
🇫🇷Angers, France
AP-HP - Hôpital Avicenne
🇫🇷Bobigny, France
CHU de Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, France
AP-HP - Hôpital Henri Mondor
🇫🇷Créteil, France
CH de Pontoise René Dubos
🇫🇷Cergy-Pontoise, France
GH Eaubonne Montmorency Hôpital Simone VEIL
🇫🇷Eaubonne, France
HCL - Hôpital Edouard Herriot
🇫🇷Lyon, France
AP-HP - Hôpital Raymond Poincaré
🇫🇷Garches, France
CHU de Grenoble - Hôpital Nord La Tronche
🇫🇷La Tronche, France
GH Sud Ile de France
🇫🇷Melun, France
AP-HP - Hôpital Lariboisière
🇫🇷Paris, France
CHU de Montpellier Site Lapeyronie
🇫🇷Montpellier, France
AP-HP - Hôpital Pitié-Salpétrière
🇫🇷Paris, France
CHU de Nantes - Hôpital Hôtel Dieu
🇫🇷Nantes, France
AP-HP - Hôpital Necker
🇫🇷Paris, France
CHU Poitiers - Hôpital la Milétrie
🇫🇷Poitiers, France
CHU Toulouse - Hôpital Purpan
🇫🇷Toulouse, France