Health TrialsbyHealthPanel

Optimisation Strategy for Emergency Tracheal Intubation

ConditionsEmergenciesOut-of-hospital SettingTracheal Intubation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Data patient

    Other intervention

    Medical History and characteristic of patient

  • Physical examination

    Other intervention

    Arterial pressure, arterial oxygen saturation, heart rate

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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 3 interventions

Trial outcomes

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.

Time frame
Day 0

Secondary outcomes

1

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
2

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
3

Difficulty of the intubation process - Alternative techniques.

Proportion of patients intubated by alternative techniques.

Time frame
Day 0
4

Difficulty of the intubation process - Intubation attempts

Mean number of intubation attempts

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
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