General Surgery Patients at the Intensive Care Unit

Not yet recruiting

• Conditions: Critical Illness; Postoperative Complications

• Registration Number: NCT06731296
• Lead Sponsor: Hospital Departamental de Villavicencio

Brief Summary

Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.

Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value \<0.05 will be selected as statistical significance.

Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality.

Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.

Detailed Description

Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored to minimize surgical or non-surgical complications. It is necessary to identify factors associated with adverse outcomes. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.

Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value \<0.05 will be selected as statistical significance.

Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality to establish predictive models of adverse outcomes in the admission to the intensive care unit to implement early preventive interventions.

Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients with a surgical diagnosis admitted to the ICU.
• Patients in the operative period admitted to the ICU.

Exclusion Criteria

• Patients admitted from another hospital.
• Surgical procedures performed in another hospital.
• Surgical patients referred to another hospital.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU mortality	30 days	ICU discharges due to patient death in the ICU.

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	30 days	ICU length of stay

Trial Locations

Locations (2)

Clinica Primavera; 🇨🇴 Villavicencio, Meta, Colombia

Hospital Departamental de Villavicencio; 🇨🇴 Villavicencio, Meta, Colombia