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Not Yet RecruitingNCT07411976

Critical Care Admission Following Emergency Department's Resuscitation Room Care

SAUV IRU: A Multicenter Prospective Observational Study Describing Resuscitation Room Activity and Comparing Critical Care Admission After Direct vs Secondary Admission

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
1,200 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEREmergency resuscitation room management (observational)Patients receive standard emergency care in the resuscitation room according to local protocols and clinician judgment. No intervention is assigned by the study. Clinical management, diagnostic procedures, and therapeutic interventions are recorded for observational purposes only.

Timeline

Start date
2026-04-01
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2026-02-17
Last updated
2026-02-17

Source: ClinicalTrials.gov record NCT07411976. Inclusion in this directory is not an endorsement.