About this trial
This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Accurate prediction of postoperative ICU admission is essential for optimizing patient safety and efficient allocation of limited critical care resources, particularly in high-risk oncologic surgical populations.
A total of 500 adult patients scheduled for elective or emergency oncologic surgery will be prospectively enrolled at a single tertiary oncology center. Preoperative clinical and demographic data, intraoperative variables, and perioperative characteristics will be recorded using a standardized data collection form. Risk assessment will include the American Society of Anesthesiologists (ASA) Physical Status classification, Surgical Outcome Risk Tool (SORT), Age-adjusted Charlson Comorbidity Index (CACI), Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels.
The primary outcome is the need for postoperative ICU admission within the first 24 hours after surgery. Secondary outcomes include unplanned ICU admission, duration of ICU stay, need for mechanical ventilation, hospital length of stay, and 30-day mortality. The predictive performance of each scoring system will be evaluated using receiver operating characteristic (ROC) analysis and multivariable logistic regression models.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older.
Patients scheduled for elective or emergency oncologic surgery.
Patients who are able to provide written informed consent.
Patients whose data will be analyzed for both planned and unplanned intensive care unit (ICU) admissions.
Disqualifiers
Patients under 18 years of age.
Patients requiring continuous ICU follow-up due to a pre-existing critical illness prior to the current surgery.
Patients who do not provide consent to participate in the study.
Trial population
The study population consists of adult patients (aged 18 and older) who are scheduled to undergo elective or emergency oncologic surgery at a single tertiary oncology training and research hospital. The population includes patients with various types of cancer requiring surgical intervention, where postoperative intensive care unit (ICU) requirement needs to be predicted using clinical risk scoring systems.
Trial design
Cohort
Prospective
Treatments tested in this trial
Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)
Other interventionThe study evaluates the predictive performance of various risk scoring systems for postoperative intensive care unit (ICU) requirement in adult patients undergoing oncologic surgery. Preoperative and intraoperative data will be collected to calculate ASA, SORT, CACI, P-POSSUM, ECOG, and NRS-2002 scores. The primary outcome is the need for ICU admission within the first 24 hours postoperatively.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Unplanned Postoperative ICU Admission
The number of participants with an unplanned admission to the ICU within the first 24 hours following oncological surgery.
Secondary outcomes
30-Day All-Cause Mortality
All-cause mortality is defined as any death, regardless of cause, occurring within 30 days following surgery. Mortality data will be collected from hospital records and verified by follow-up (including telephone contact if required). Both in-hospital deaths and deaths occurring after discharge within the 30-day postoperative period will be included in the analysis.
Duration of ICU Stay (in Days)
Total number of days spent in the intensive care unit from the date of ICU admission until the date of ICU discharge during the index hospitalization.
Number of Participants Requiring Mechanical Ventilation within 24 Hours after Surgery
Mechanical ventilation requirement is defined as the need for invasive ventilatory support within the first 24 hours after surgery. Data will be obtained from anesthesia and postoperative care records.
Length of Hospital Stay (in Days)
Total number of days from hospital admission to official hospital discharge.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.