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

Complication,Postoperative Clinical Trial

— OPICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995925
• Other study ID #: 2023.198.IRB1.065
• Status: Recruiting
• Start date: January 3, 2024
• Est. completion date: April 3, 2024

Study information

• Verified date: January 2024
• Source: Koç University
• Contact: Evren Senturk, Prof, MD
• Phone: +90 212 338 10 00
• Email: esenturk[@]ku.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: April 3, 2024
• Est. primary completion date: February 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Indication, Unlabeled
• Postoperative Complications

Intervention

Other:
• Clinical Observation
Clinical Observation

Locations

Country	Name	City	State
Turkey	Koc University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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- — View 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 Anaes — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of postoperative complications	They will be assessed postoperatively using Clavien- Dindo classification	From the end of the surgery until discharge from the hospital
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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