SAUV IRU: A Multicenter Prospective Observational Study Describing Resuscitation Room Activity and Comparing Critical Care Admission After Direct vs Secondary Admission
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,629
- Locations
- 1
- Primary Endpoint
- Critical care admission within 24 hours after resuscitation room admission
Study Overview
Brief Summary
This prospective multicenter observational study aims to describe resuscitation room activity in France and to compare critical care admission within 24 hours between patients directly admitted to the resuscitation room and those admitted secondarily after initial emergency department management. Adult patients admitted to the resuscitation room over a 72-hour period in participating centers will be included. Data collection includes patient characteristics, triage severity, physiological parameters, critical interventions, and outcomes at 24 hours.
Detailed Description
This is a prospective, multicenter, observational cohort study including all consecutive adult patients admitted to the resuscitation room in participating emergency departments over a predefined 72-hour study period. Patients are categorized according to their mode of admission to the resuscitation room (direct or secondary after initial emergency department management). No intervention is assigned by the study, and patient care follows usual practice and local protocols. Data collection includes patient-level clinical and physiological variables, resuscitation room processes of care, organizational characteristics at the center level, and practitioner-level characteristics. The primary outcome is critical care admission or death within 24 hours after resuscitation room admission.
Statistical analysis Analyses will be conducted in adult patients (≥18 years) admitted to the resuscitation room. Patients will be categorized according to the mode of resuscitation room admission (direct vs secondary).
The primary outcome is critical care admission or death within 24 hours after resuscitation room admission. The primary analysis will compare the proportion of patients meeting the primary outcome between groups using logistic regression, with adjustment for prespecified baseline variables and center effects. Results will be reported as odds ratios with 95% confidence intervals. Secondary and prespecified outcomes will be analyzed descriptively. Missing data will be described and analyses performed on available data.
An ancillary analysis will be conducted among patients who receive blood transfusion during resuscitation room management. This ancillary study will use the same prospective observational dataset and will not involve any additional data collection or modification of patient management. Analyses will focus on patient characteristics, indications for transfusion, transfusion practices, and short-term outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (≥18 years old) admitted to the resuscitation room during the study period.
Exclusion Criteria
- •Patients younger than 18 years.
Arms & Interventions
Direct resuscitation room admission
Adult patients (≥18 years old) admitted directly to the resuscitation room from the prehospital setting or immediately upon arrival at the emergency department, without prior clinical management in another emergency department area.
Intervention: Emergency resuscitation room management (observational) (Other)
Secondary resuscitation room admission
Adult patients (≥18 years old) admitted to the resuscitation room secondarily, after an initial evaluation or management in another emergency department area (e.g., standard treatment area, waiting area, imaging unit, or other hospital sector), before transfer to the resuscitation room.
Intervention: Emergency resuscitation room management (observational) (Other)
Outcomes
Primary Outcomes
Critical care admission within 24 hours after resuscitation room admission
Time Frame: Within 24 hours after resuscitation room admission
Proportion of patients admitted to critical care (intensive care unit or intermediate care unit) or deceased within 24 hours following admission to the resuscitation room, comparing direct versus secondary resuscitation room admission.
Secondary Outcomes
- Physiological severity at resuscitation room admission-part 8(Baseline)
- All-cause mortality within 24 hours(Within 24 hours after resuscitation room admission)
- Physiological severity at resuscitation room admission-part 5(Baseline)
- Physiological severity at resuscitation room admission-part 6(Baseline)
- Physiological severity at resuscitation room admission-part 7(Baseline)
- Use of critical care interventions in the resuscitation room(Day 1)
- Center-level organizational characteristics(Baseline (during study period))
- Physiological severity at resuscitation room admission-part 1(Baseline)
- Physiological severity at resuscitation room admission-part 2(Baseline)
- Physiological severity at resuscitation room admission-part 3(Baseline)
- Physiological severity at resuscitation room admission-part 4(Baseline)