Critical IllnessSAUV-IRUNCT07411976
Critical Care Admission Following Emergency Department's Resuscitation Room Care
An observational study of Critical Illness and Emergency Department Patient, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Emergency Department Patient, Shock
- What is being tested?
- Emergency resuscitation room management (observational)
- How many people
- 1,629 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 3 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years old) admitted to the resuscitation room of participating emergency departments during the study period. All eligible patients admitted directly or secondarily to the resuscitation room are included consecutively, without intervention assignment. Patients are managed according to usual care and local protocols.
Who may be able to join
- Adult patients (≥18 years old) admitted to the resuscitation room during the study period.
Who cannot join
- Patients younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAUV IRU: A Multicenter Prospective Observational Study Describing Resuscitation Room Activity and Comparing Critical Care Admission After Direct vs Secondary Admission
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.
Read the 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
- Critical Illness, Emergency Department Patient, Shock, Trauma (Including Fractures), Respiratory Failure, Resuscitation
- Being tested
- Emergency resuscitation room management (observational)
- Keywords
- Emergency Department, Resuscitation Room, Critical Care Admission
- Medical subject headings
- Critical Illness, Shock, Wounds and Injuries, Respiratory Insufficiency, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency resuscitation room management (observational)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Emergency resuscitation room management (observational) | |
| 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. Receives: Other: Emergency resuscitation room management (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical care admission 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.
Measured: Within 24 hours after resuscitation room admission
Secondary outcomes (11)
All-cause mortality within 24 hours
All-cause mortality occurring within 24 hours after resuscitation room admission.
Measured: Within 24 hours after resuscitation room admission
Use of critical care interventions in the resuscitation room
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.
Measured: Day 1
Center-level organizational characteristics
Description of resuscitation room organizational characteristics, including material resources, human resources, and availability of critical care equipment.
Measured: Baseline (during study period)
Physiological severity at resuscitation room admission-part 1
Blood pressure at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 2
Heart rate at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 3
Respiratory rate at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 4
Pulsed oxygen saturation at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 5
Temperature at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 6
Glasgow Coma Scale at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 7
Capillary blood glucose at admission
Measured: Baseline
Physiological severity at resuscitation room admission-part 8
Capillary blood glucose at admission
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,629 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Française de Medecine d'urgence
- Responsible party
- Sponsor
- Investigators
- Romain Genre Grandpierre, MD, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411976
- Sponsor's protocol ID
- IRB CHU Nîmes 25.11.01
- Acronym
- SAUV-IRU
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this observational study does not include a data sharing plan and data use is restricted to the objectives defined in the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAUV IRU: A Multicenter Prospective Observational Study Describing Resuscitation Room Activity and Comparing Critical Care Admission After Direct vs Secondary Admission
- ClinicalTrials.gov ID
- NCT07411976
- Acronym / sponsor ID
- SAUV-IRU / IRB CHU Nîmes 25.11.01
- Conditions
- Critical Illness, Emergency Department Patient, Shock, Trauma (Including Fractures), Respiratory Failure, Resuscitation
- Keywords
- Emergency Department, Resuscitation Room, Critical Care Admission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,629 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Societe Française de Medecine d'urgence
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct resuscitation room admission | – | Other: Emergency resuscitation room management (observational)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. |
| Secondary resuscitation room admission | – | Other: Emergency resuscitation room management (observational)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years old) admitted to the resuscitation room of participating emergency departments during the study period. All eligible patients admitted directly or secondarily to the resuscitation room are included consecutively, without intervention assignment. Patients are managed according to usual care and local protocols.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years old) admitted to the resuscitation room during the study period.
Key exclusion criteria (1 listed)
- Patients younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency 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. | Other | Direct resuscitation room admission, Secondary resuscitation room admission |
Primary outcome
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.
11 secondary outcomes
All-cause mortality within 24 hours
Time frame: Within 24 hours after resuscitation room admission
Use of critical care interventions in the resuscitation room
Time frame: Day 1
Center-level organizational characteristics
Time frame: Baseline (during study period)
Physiological severity at resuscitation room admission-part 1
Time frame: Baseline
Physiological severity at resuscitation room admission-part 2
Time frame: Baseline
Physiological severity at resuscitation room admission-part 3
Time frame: Baseline
Physiological severity at resuscitation room admission-part 4
Time frame: Baseline
Physiological severity at resuscitation room admission-part 5
Time frame: Baseline
Physiological severity at resuscitation room admission-part 6
Time frame: Baseline
Physiological severity at resuscitation room admission-part 7
Time frame: Baseline
Physiological severity at resuscitation room admission-part 8
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this observational study does not include a data sharing plan and data use is restricted to the objectives defined in the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Genre Grandpierre, MD principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Emergency Department Patient, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical care admission within 24 hours after resuscitation room admission (time frame: Within 24 hours after resuscitation room admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.