Clinical trial NCT05995925: Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)
Official title: Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Indication, Unlabeled
Complication,Postoperative
Keywords: Intensive Care
Triage
Postoperative period
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients requiring intensive care treatment in the postoperative period.

The study population comprises individuals who have undergone surgery and require intensive care, regardless of whether their admission to the ICU was planned or unplanned.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effective use of ICU
timeFrame: From 1 day before the surgery to the 30th day after the surgery.
Secondary outcomes:
measure: Rates of postoperative complications
timeFrame: From the end of the surgery until discharge from the hospital
measure: Length of ICU stay
timeFrame: From the end of the surgery until discharge from the ICU
measure: Length of hospital stay.
timeFrame: From the end of the surgery until discharge from the hospital
measure: ICU mortality
timeFrame: From the end of the surgery until discharge from the ICU
measure: 30-day hospital mortality
timeFrame: From the end of the surgery until discharge from the hospital
measure: Best scoring system for ICU admission
timeFrame: Preoperative from hospital admission until the patient's discharge from hospital following surgery.
measure: Epidemiology of postoperative ICU admitted patients
timeFrame: From preoperative hospital admission until discharge from the hospital
measure: Risk factors or criteria for ICU admission after the surgery
timeFrame: From preoperative hospital admission until discharge from the hospital
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Nahit Cakar, Prof, MD
role: STUDY_CHAIR
References:
citation: Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
citation: Jerath A, Laupacis A, Austin PC, Wunsch H, Wijeysundera DN. Intensive care utilization following major noncardiac surgical procedures in Ontario, Canada: a population-based study. Intensive Care Med. 2018 Sep;44(9):1427-1435. doi: 10.1007/s00134-018-5330-6. Epub 2018 Jul 27.
citation: Zampieri FG, Lone NI, Bagshaw SM. Admission to intensive care unit after major surgery. Intensive Care Med. 2023 May;49(5):575-578. doi: 10.1007/s00134-023-07026-7. Epub 2023 Mar 22. No abstract available.