Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05539391

Optimisation Strategy for Emergency Tracheal Intubation

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data patient

Other

Medical History and characteristic of patient

physical examination

Other

Arterial pressure, arterial oxygen saturation, heart rate

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.

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.

Primary outcomes

  1. Severe intubation-related complications occurring during the first hour after intubation

    Time frame: 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 outcomes

  1. Difficulty of the intubation process - Intubation Difficulty

    Time frame: Day 0

    Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.

  2. Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen

    Time frame: Day 0

    Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable

  3. Difficulty of the intubation process - Alternative techniques.

    Time frame: Day 0

    Proportion of patients intubated by alternative techniques.

  4. Difficulty of the intubation process - Intubation attempts

    Time frame: Day 0

    Mean number of intubation attempts

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

    Time frame: Day 0

    Mean number of intubation failures under direct laryngoscopy.

  6. Out-of hospital care -Time of out-of-hospital care

    Time frame: Day 0

    Mean time of out-of-hospital care (in minutes)

  7. Out-of hospital care - sedative drugs

    Time frame: Day 0

    Mean total amount of sedative drugs used after intubation

  8. Out-of hospital care - vasopressors

    Time frame: Day 0

    Mean total amount of vasopressors used after intubation

  9. Out-of hospital care : Mortality

    Time frame: Day 0

    Out-of-hospital mortality.

  10. Mortality

    Time frame: Day 28

    Vital status

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier COMBES, Pr

CONTACT

[email protected]

05 56 79 49 47 ext. 033

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial

Acronym: OSETIM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.