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

NCT05995925 | Unknown

• 1 other identifier: 2023.198.IRB1.065
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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).

Conditions

Indication, Unlabeled; Complication,Postoperative

Keywords

Intensive Care; Triage; Postoperative period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Rates of postoperative complications

  From the end of the surgery until discharge from the hospital

• Length of ICU stay

  From the end of the surgery until discharge from the ICU

• Length of hospital stay.

  From the end of the surgery until discharge from the hospital

• ICU mortality

  From the end of the surgery until discharge from the ICU

• 30-day hospital mortality

  From the end of the surgery until discharge from the hospital

Study Arms (2)

Patients with planned ICU admission

Patients with preoperative planned ICU admission

Other: Clinical Observation

Patients with unplanned ICU admission

Patients with preoperative unplanned ICU admission

Other: Clinical Observation

Interventions

Clinical Observation OTHER

Clinical Observation

Patients with planned ICU admission; Patients with unplanned ICU admission

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, 34450, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 22998715 RESULT

• 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.

  PMID: 30054691 RESULT

• 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.

  PMID: 36947198 RESULT

MeSH Terms

Conditions

Postoperative Complications

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Nahit Cakar, Prof, MD

  Koç University

  STUDY CHAIR

Central Study Contacts

Evren Senturk, Prof, MD

CONTACT

+90 212 338 10 00; esenturk@ku.edu.tr

Bulent Gucyetmez, Assoc.Prof

CONTACT

+90 212 468 44 44; bulentgucyetmez@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: January 3, 2024
• Primary Completion: February 3, 2024
• Study Completion: April 3, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

TU (1)