Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on postintubation Morbidity: A cluster randomized controlled trial

Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on postintubation Morbidity: A cluster randomized controlled trial - OSETIM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002686-15-FR

Enrollment

1500

Registered

2022-08-05

Start date

2022-10-18

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress

Interventions

Trade Name: ROCURONIUM Product Name: Rocuronium Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Rocuronium bromide Other descriptive name: Rocunorium Concentration unit: mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult (= 18 years) patient presenting with vital distress needing an emergency endotracheal intubation , and treated by the participating SMUR. - Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB e as an aid for tracheal intubation to the usual tracheal intubation process on early post-intubation related complications, in adult patients needing out-of-hospital emergency tracheal intubation.;Secondary Objective: To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB to the usual tracheal intubation process in adult patients needing out-of-hospital emergency tracheal intubation, on: - intubation difficulty, - out-of hospital care and mortality, - 28-days mortality. ;Primary end point(s): The primary endpoint will be the 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. ;Timepoint(s) of evaluation of this end point: During out-of-hospital treatment	—

Measure

Time frame

Main Objective: To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB e as an aid for tracheal intubation to the usual tracheal intubation process on early post-intubation related complications, in adult patients needing out-of-hospital emergency tracheal intubation.;Secondary Objective: To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB to the usual tracheal intubation process in adult patients needing out-of-hospital emergency tracheal intubation, on: - intubation difficulty, - out-of hospital care and mortality, - 28-days mortality. ;Primary end point(s): The primary endpoint will be the 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. ;Timepoint(s) of evaluation of this end point: During out-of-hospital treatment

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Secondary

Measure	Time frame
Secondary end point(s): Difficulty of the intubation process: These outcomes will be collected by the emergency physician in charge of the patient. - Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18 - Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions - Proportion of patients intubated by alternative techniques (stylet, gum elastic bougie, Intubating Laryngeal Mask Airway (ILMA) [e.g., Fastrach], or cricothyrotomy). - Mean number of intubation attempts. - Mean number of intubation failures under direct laryngoscopy. Out-of hospital care: These outcomes will be collected by the emergency physician in charge of the patient. - Mean time of out-of-hospital care (in minutes), defined from time of SMUR arrival on scene to time of hospitalization. - Mean total amount of sedative drugs used after intubation. - Mean total amount of vasopressors used after intubation. - Out-of-hospital mortality, defined as the proportion of patients who died during the out-of-hospital time. Mortality at 28 days: The follow-up of patients stopping at hospital admission, the vital status of the patient will be retrieved using the open-access French Register of deceased persons (“Fichier des personnes décédées”) maintained by INSEE (website: https://deces.matchid.io/search). ;Timepoint(s) of evaluation of this end point: During out-of-hospital treatment and at 28 days for the mortality	—

Measure

Time frame

Secondary end point(s): Difficulty of the intubation process: These outcomes will be collected by the emergency physician in charge of the patient. - Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18 - Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions - Proportion of patients intubated by alternative techniques (stylet, gum elastic bougie, Intubating Laryngeal Mask Airway (ILMA) [e.g., Fastrach], or cricothyrotomy). - Mean number of intubation attempts. - Mean number of intubation failures under direct laryngoscopy. Out-of hospital care: These outcomes will be collected by the emergency physician in charge of the patient. - Mean time of out-of-hospital care (in minutes), defined from time of SMUR arrival on scene to time of hospitalization. - Mean total amount of sedative drugs used after intubation. - Mean total amount of vasopressors used after intubation. - Out-of-hospital mortality, defined as the proportion of patients who died during the out-of-hospital time. Mortality at 28 days: The follow-up of patients stopping at hospital admission, the vital status of the patient will be retrieved using the open-access French Register of deceased persons (“Fichier des personnes décédées”) maintained by INSEE (website: https://deces.matchid.io/search). ;Timepoint(s) of evaluation of this end point: During out-of-hospital treatment and at 28 days for the mortality

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Countries

France

Contacts

Public ContactClinical Trials Manager

CHU de Bordeaux

christelle.turuban@chu-bordeaux.fr33557821065

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026