Optimisation Strategy for Emergency Tracheal Intubation (OSETIM)

September 23, 2025 updated by: University Hospital, Bordeaux

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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.
Other: Data patient
Medical History and characteristic of patient
Other: Physical examination
Arterial pressure, arterial oxygen saturation, heart rate
Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
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.
Active Comparator: Control Group
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.
Other: Data patient
Medical History and characteristic of patient
Other: Physical examination
Arterial pressure, arterial oxygen saturation, heart rate
Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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
Day 0
Difficulty of the intubation process - Alternative techniques.
Time Frame: Day 0
Proportion of patients intubated by alternative techniques.
Day 0
Difficulty of the intubation process - Intubation attempts
Time Frame: Day 0
Mean number of intubation attempts
Day 0
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Time Frame: Day 0
Mean number of intubation failures under direct laryngoscopy.
Day 0
Out-of hospital care -Time of out-of-hospital care
Time Frame: Day 0
Mean time of out-of-hospital care (in minutes)
Day 0
Out-of hospital care - sedative drugs
Time Frame: Day 0
Mean total amount of sedative drugs used after intubation
Day 0
Out-of hospital care - vasopressors
Time Frame: Day 0
Mean total amount of vasopressors used after intubation
Day 0
Out-of hospital care : Mortality
Time Frame: Day 0
Out-of-hospital mortality.
Day 0
Mortality
Time Frame: Day 28
Vital status
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Xavier COMBES, Pr, Université Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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