Optimisation Strategy for Emergency Tracheal Intubation

University Hospital, Bordeaux1,500 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,500

Conditions

Emergencies Out-of-hospital Setting Tracheal Intubation

Interventions

Data patientOTHER

Medical History and characteristic of patient

Physical examinationOTHER

Arterial pressure, arterial oxygen saturation, heart rate

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

CHU d'Angers

Angers, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Day 0

Secondary Outcomes

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.

Time frame: Day 0

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

Time frame: Day 0

Difficulty of the intubation process - Alternative techniques.

Proportion of patients intubated by alternative techniques.

Time frame: Day 0

Difficulty of the intubation process - Intubation attempts

Mean number of intubation attempts

Time frame: Day 0

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

Mean number of intubation failures under direct laryngoscopy.

Central Contacts

Xavier COMBES, Pr

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.