Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)
- Conditions
- Indication, UnlabeledComplication,Postoperative
- Interventions
- Other: Clinical Observation
- Registration Number
- NCT05995925
- Lead Sponsor
- Koç University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with planned ICU admission Clinical Observation Patients with preoperative planned ICU admission Patients with unplanned ICU admission Clinical Observation Patients with preoperative unplanned ICU admission
- Primary Outcome Measures
Name Time Method Effective use of ICU From 1 day before the surgery to the 30th day after the surgery. To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units.
- Secondary Outcome Measures
Name Time Method Length of ICU stay From the end of the surgery until discharge from the ICU The patient will be followed up from admission to the ICU until discharge from the ICU
Length of hospital stay. From the end of the surgery until discharge from the hospital The patient will be followed up from admission to the ICU until discharge from the hospital
ICU mortality From the end of the surgery until discharge from the ICU The patient will be followed up from admission to the ICU until discharge from the ICU
Risk factors or criteria for ICU admission after the surgery From preoperative hospital admission until discharge from the hospital During the entire perioperative process, the patient will be closely observed, vital signs, treatments and complications will be recorded.
Rates of postoperative complications From the end of the surgery until discharge from the hospital They will be assessed postoperatively using Clavien- Dindo classification
30-day hospital mortality From the end of the surgery until discharge from the hospital The patient will be followed up from admission to the ICU until his discharge from the hospital
Best scoring system for ICU admission Preoperative from hospital admission until the patient's discharge from hospital following surgery. Identifying the best scoring system for ICU admission by comparing different scoring systems.
Epidemiology of postoperative ICU admitted patients From preoperative hospital admission until discharge from the hospital Defining groups in postoperative patients according to their region or type of surgery
Trial Locations
- Locations (1)
Koc University
🇹🇷Istanbul, Turkey