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

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514913-37-00
Acronym
CHUBX 2021/25
Enrollment
1500
Registered
2024-09-12
Start date
2023-01-12
Completion date
Unknown
Last updated
2025-09-03

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

Conditions

Respiratory distress

Brief summary

proportion of patients with severe intubation-related complications occurring during the first hour after intubation. 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. Esophageal intubation. Unintentional extubation.

Detailed description

Difficulty of the intubation process: Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18, Difficulty of the intubation process: Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions, Difficulty of the intubation process: Proportion of patients intubated by alternative techniques (stylet, gum elastic bougie, Intubating Laryngeal Mask Airway (ILMA) [e.g., Fastrach], or cricothyrotomy), Difficulty of the intubation process: Mean number of intubation attempts, Difficulty of the intubation process: Mean number of intubation failures under direct laryngoscopy, Out-of hospital care: Mean time of out-of-hospital care (in minutes), defined from time of SMUR arrival on scene to time of hospitalization, Out-of hospital care: Mean total amount of sedative drugs used after intubation, Out-of hospital care: Mean total amount of vasopressors used after intubation, Out-of hospital care: 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)

Interventions

DRUGCELOCURINE 50 mg/ml
DRUGsolution injectable
DRUGSUGAMMADEX JUTA PHARMA 100 mg/mL
DRUGROCURONIUM VIATRIS 10 mg/mL

Sponsors

Centre Hospitalier Universitaire De Bordeaux
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
proportion of patients with severe intubation-related complications occurring during the first hour after intubation. 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. Esophageal intubation. Unintentional extubation.

Secondary

MeasureTime frame
Difficulty of the intubation process: Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18, Difficulty of the intubation process: Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions, Difficulty of the intubation process: Proportion of patients intubated by alternative techniques (stylet, gum elastic bougie, Intubating Laryngeal Mask Airway (ILMA) [e.g., Fastrach], or cricothyrotomy), Difficulty of the intubation process: Mean number of intubation attempts, Difficulty of the intubation process: Mean number of intubation failures under direct laryngoscopy, Out-of hospital care: Mean time of out-of-hospital care (in minutes), defined from time of SMUR arrival on scene to time of hospitalization, Out-of hospital care: Mean total amount of sedative drugs used after intubation, Out-of hospital care: Mean total amount of vasopressors used after intubation, Out-of hospital care: Out-of-hospital

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026