ROCURONIUM BROMIDE for Respiratory distress

Inclusion criteria

• {"criterion_text":"- Adult (≥ 18 years) patient presenting with vital distress needing an emergency endotracheal intubation , and treated by the participating SMUR"}
• {"criterion_text":"- Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest"}

Exclusion criteria

• {"criterion_text":"- Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist)"}
• {"criterion_text":"- Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis)"}
• {"criterion_text":"- Patient that are not members of a medical aid scheme (beneficiary or main member)"}
• {"criterion_text":"- Patient under specific protection measures: pregnant, parturient or nursing women ; legal protection or deprived of liberty : patient under judicial protection, patient under guardianship/curatorship"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Severe intubation-related complications defined as: Cardiac arrest; ≥1 arterial hypotension episode (systolic BP < 90 mmHg); ≥1 hypoxemia episode (new occurrence of oxygen saturation <90%); severe cardiac arrhythmia (ventricular tachycardia); pulmonary aspiration; esophageal intubation; unintentional extubation. Measured as proportion of patients experiencing these events during the first hour after intubation."}

Secondary endpoints

• {"endpoint_text":"- Difficulty of the intubation process: Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18","definition_or_measurement_approach":"Proportion of patients with Intubation Difficulty Score (IDS) > 5 defining difficult intubation."}
• {"endpoint_text":"- Difficulty of the intubation process: Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions","definition_or_measurement_approach":"Intubation conditions assessed using the Copenhagen score categorized as Poor / Good / Excellent."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion of patients requiring alternative intubation techniques (stylet, gum elastic bougie, ILMA, or cricothyrotomy)."}
• {"endpoint_text":"- Difficulty of the intubation process: Mean number of intubation attempts","definition_or_measurement_approach":"Mean (average) number of intubation attempts per patient."}
• {"endpoint_text":"- Difficulty of the intubation process: Mean number of intubation failures under direct laryngoscopy","definition_or_measurement_approach":"Mean number of intubation failures when using direct laryngoscopy."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Mean duration (minutes) of out-of-hospital care measured from SMUR arrival on scene to hospital admission."}
• {"endpoint_text":"- Out-of hospital care: Mean total amount of sedative drugs used after intubation","definition_or_measurement_approach":"Mean total quantity of sedative drugs administered after intubation (specific measurement units not provided)."}
• {"endpoint_text":"- Out-of hospital care: Mean total amount of vasopressors used after intubation","definition_or_measurement_approach":"Mean total quantity of vasopressors administered after intubation (specific measurement units not provided)."}
• {"endpoint_text":"- Out-of hospital care: Out-of-hospital mortality, defined as the proportion of patients who died during the out-of-hospital time","definition_or_measurement_approach":"Proportion of patients who died during the out-of-hospital time."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Vital status at 28 days obtained via the French Register of deceased persons (INSEE) to determine 28-day mortality."}

Methods

• Enrolment occurs via participating SMUR (emergency medical service) teams during out-of-hospital emergency tracheal intubations in France; patients are identified and enrolled at the point of care by treating SMUR clinicians.

France

Earliest CTIS Part Ii Submission Date

31-07-2024

Latest Decision Or Authorization Date

03-09-2025

Processing Time Days

399

Number Of Sites

19

Number Of Participants

1500

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France