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Optimisation Strategy for Emergency Tracheal Intubation (OSETIM)

Primary Purpose

Emergencies, Out-of-hospital Setting, Tracheal Intubation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Data patient
Physical examination
Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
Rapid sequence intubation (RSI) : Recommendations for emergency intubation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergencies focused on measuring Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation, Rocuronium, Gum Elastic Bougie

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pellegrin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2022
Last Updated
October 5, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05539391
Brief Title
Optimisation Strategy for Emergency Tracheal Intubation
Acronym
OSETIM
Official Title
Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Out-of-hospital Setting, Tracheal Intubation
Keywords
Out-of-hospital, Intubation, Complications, Vital distress, Rapid sequence intubation, Rocuronium, Gum Elastic Bougie

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Data patient
Intervention Description
Medical History and characteristic of patient
Intervention Type
Other
Intervention Name(s)
Physical examination
Intervention Description
Arterial pressure, arterial oxygen saturation, heart rate
Intervention Type
Procedure
Intervention Name(s)
Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rapid sequence intubation (RSI) : Recommendations for emergency intubation
Intervention Description
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 Outcome Measure Information:
Title
Severe intubation-related complications occurring during the first hour after intubation
Description
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 Outcome Measure Information:
Title
Difficulty of the intubation process - Intubation Difficulty
Description
Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.
Time Frame
Day 0
Title
Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen
Description
Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable
Time Frame
Day 0
Title
Difficulty of the intubation process - Alternative techniques.
Description
Proportion of patients intubated by alternative techniques.
Time Frame
Day 0
Title
Difficulty of the intubation process - Intubation attempts
Description
Mean number of intubation attempts
Time Frame
Day 0
Title
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Description
Mean number of intubation failures under direct laryngoscopy.
Time Frame
Day 0
Title
Out-of hospital care -Time of out-of-hospital care
Description
Mean time of out-of-hospital care (in minutes)
Time Frame
Day 0
Title
Out-of hospital care - sedative drugs
Description
Mean total amount of sedative drugs used after intubation
Time Frame
Day 0
Title
Out-of hospital care - vasopressors
Description
Mean total amount of vasopressors used after intubation
Time Frame
Day 0
Title
Out-of hospital care : Mortality
Description
Out-of-hospital mortality.
Time Frame
Day 0
Title
Mortality
Description
Vital status
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier COMBES, Pr
Phone
05 56 79 49 47
Ext
033
Email
xavier.combes@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier COMBES, Pr
Organizational Affiliation
Université Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pellegrin Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier COMBES, Pr
First Name & Middle Initial & Last Name & Degree
Xavier COMBES, PR

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimisation Strategy for Emergency Tracheal Intubation

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