Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)

Study Overview
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Brief Summary
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This clinical trial will be carried out as a national multicenter observational cohort trial in Turkey. Our starting point is the need to triage postoperative patients daily due to the limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring emergency or unplanned ICU admission generally meet the ICU admission criteria. However, postoperative patients admitted to the ICU for planned reasons often do not meet the ICU admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit - PACU) for close observation purposes. The primary aim is to assess the efficient utilization of ICU beds. We try to compare the treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU admission. Our secondary outcome is to identify criteria that can predict ICU indications based on patients' preoperative characteristics and evaluate the postoperative complications according to the Clavien-Dindo classification. Our aim is to categorize patients admitted to the ICU into two groups: planned and unplanned/emergency cases and compare the necessity of ICU care between these two groups. The need for ICU treatment will be determined based on the criteria established in the following* study. The presence of any of these criteria will indicate the need for ICU admission, while the absence of these criteria may identify patients admitted to the ICU only for monitoring purposes (i.e., unnecessary ICU admissions).

Detailed Description
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Surgical cases involving patients over 18 years of age requiring postoperative intensive care will be included (including patients who were admitted urgently, or patients that is planned but not admitted to ICU after the surgery). Cardiac surgery cases, outpatient cases, pediatric surgery cases, patients undergoing surgery while hospitalized in the ICU, patients undergoing only interventional procedures, and those who do not provide consent will be excluded from the study.

Official Title
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Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)

Conditions
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Indication, Unlabeled, Complication,Postoperative

Intervention / Treatment
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* Other: Clinical Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Major elective/emergency surgical procedures Planned, unplanned, emergent surgical procedures, planned but not admitted to the ICU after the operation. Patients who planned but not transferred to the ICU will also be followed/ included postoperatively Informed Consent Major surgeries will be targeted within the broad subgroup domains of gynecology, neurosurgery, thoracic, urology, orthopedics/trauma, and abdominal surgery. Unplanned but admitted to ICU after surgery in 48 hrs. Exclusion Criteria: Day-case surgery Cardiac surgery Pediatric surgery Patients who were already staying in ICU and planned to be operated on Denial of informed consent All interventional procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with planned ICU admission<br>Patients with preoperative planned ICU admission | Other: Clinical Observation<br>* Clinical Observation<br>|
| Patients with unplanned ICU admission<br>Patients with preoperative unplanned ICU admission | Other: Clinical Observation<br>* Clinical Observation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective use of ICU | To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units. | From 1 day before the surgery to the 30th day after the surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of postoperative complications | They will be assessed postoperatively using Clavien- Dindo classification | From the end of the surgery until discharge from the hospital | 
| Length of ICU stay | The patient will be followed up from admission to the ICU until discharge from the ICU | From the end of the surgery until discharge from the ICU | 
| Length of hospital stay. | The patient will be followed up from admission to the ICU until discharge from the hospital | From the end of the surgery until discharge from the hospital | 
| ICU mortality | The patient will be followed up from admission to the ICU until discharge from the ICU | From the end of the surgery until discharge from the ICU | 
| 30-day hospital mortality | The patient will be followed up from admission to the ICU until his discharge from the hospital | From the end of the surgery until discharge from the hospital | 
| Best scoring system for ICU admission | Identifying the best scoring system for ICU admission by comparing different scoring systems. | Preoperative from hospital admission until the patient's discharge from hospital following surgery. | 
| Epidemiology of postoperative ICU admitted patients | Defining groups in postoperative patients according to their region or type of surgery | From preoperative hospital admission until discharge from the hospital | 
| Risk factors or criteria for ICU admission after the surgery | During the entire perioperative process, the patient will be closely observed, vital signs, treatments and complications will be recorded. | From preoperative hospital admission until discharge from the hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care, Triage, Postoperative period