Clinical trial NCT06731296: General Surgery Patients at the Intensive Care Unit
Official title: Characteristics of General Surgery Patients Admitted to the Intensive Care Unit, Villavicencio, 2022-2024.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Illness
Postoperative Complications
Keywords: Acute Care Surgery
Operative Surgical Procedures
Perioperative Care
Critical Care
Intensive Care Units
In-hospital Mortality
Colombia
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General surgery patients admitted to the ICU, especially for postoperative care.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU mortality
timeFrame: 30 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Clinica Primavera
state: Meta
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera
name: Norton Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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