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

January 29, 2024 updated by: Evren Senturk, Koç University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34450
        • Recruiting
        • Koç University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with planned ICU admission
Patients with preoperative planned ICU admission
Other: Clinical Observation
Clinical Observation
Patients with unplanned ICU admission
Patients with preoperative unplanned ICU admission
Other: Clinical Observation
Clinical Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective use of ICU
Time Frame: 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.
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
Time Frame: From the end of the surgery until discharge from the hospital
They will be assessed postoperatively using Clavien- Dindo classification
From the end of the surgery until discharge from the hospital
Length of ICU stay
Time Frame: 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
From the end of the surgery until discharge from the ICU
Length of hospital stay.
Time Frame: 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
From the end of the surgery until discharge from the hospital
ICU mortality
Time Frame: 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
From the end of the surgery until discharge from the ICU
30-day hospital mortality
Time Frame: 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
From the end of the surgery until discharge from the hospital
Best scoring system for ICU admission
Time Frame: 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.
Preoperative from hospital admission until the patient's discharge from hospital following surgery.
Epidemiology of postoperative ICU admitted patients
Time Frame: From preoperative hospital admission until discharge from the hospital
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
Time Frame: 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.
From preoperative hospital admission until discharge from the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Study Chair: Nahit Cakar, Prof, MD, Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

February 3, 2024

Study Completion (Estimated)

April 3, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.198.IRB1.065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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