- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411976
Critical Care Admission Following Emergency Department's Resuscitation Room Care (SAUV-IRU)
SAUV IRU: A Multicenter Prospective Observational Study Describing Resuscitation Room Activity and Comparing Critical Care Admission After Direct vs Secondary Admission
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Romain Genre Grandpierre, MD
- Phone Number: +33674827514
- Email: romain.genregrandpierre@chu-nimes.fr
Study Contact Backup
- Name: Fabien Coisy, MD, MSc
- Email: fabien.coisy@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥18 years old) admitted to the resuscitation room during the study period.
Exclusion Criteria:
- Patients younger than 18 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 24 hours after resuscitation room admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality within 24 hours
Time Frame: Within 24 hours after resuscitation room admission
|
All-cause mortality occurring within 24 hours after resuscitation room admission.
|
Within 24 hours after resuscitation room admission
|
|
Use of critical care interventions in the resuscitation room
Time Frame: Day 1
|
Proportion of patients receiving at least one critical care intervention in the resuscitation room, including airway management, mechanical ventilation or non-invasive ventilation, vasopressor therapy, transfusion, renal replacement therapy, or cardiopulmonary resuscitation.
|
Day 1
|
|
Center-level organizational characteristics
Time Frame: Baseline (during study period)
|
Description of resuscitation room organizational characteristics, including material resources, human resources, and availability of critical care equipment.
|
Baseline (during study period)
|
|
Physiological severity at resuscitation room admission-part 1
Time Frame: Baseline
|
Blood pressure at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 2
Time Frame: Baseline
|
Heart rate at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 3
Time Frame: Baseline
|
Respiratory rate at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 4
Time Frame: Baseline
|
Pulsed oxygen saturation at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 5
Time Frame: Baseline
|
Temperature at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 6
Time Frame: Baseline
|
Glasgow Coma Scale at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 7
Time Frame: Baseline
|
Capillary blood glucose at admission
|
Baseline
|
|
Physiological severity at resuscitation room admission-part 8
Time Frame: Baseline
|
Capillary blood glucose at admission
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time from emergency department arrival to resuscitation room admission
Time Frame: Day 1
|
Time interval between emergency department arrival and resuscitation room admission
|
Day 1
|
|
Blood transfusion during resuscitation room management
Time Frame: Day 1
|
Proportion of patients receiving at least one blood product transfusion during resuscitation room management.
|
Day 1
|
|
Specialist consultation in the resuscitation room
Time Frame: Day 1
|
Proportion of patients requiring at least one specialist consultation during resuscitation room management.
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Romain Genre Grandpierre, MD, Nimes University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB CHU Nîmes 25.11.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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