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General Surgery Patients at the Intensive Care Unit (TraViII)

H

Hospital Departamental de Villavicencio

Status

Begins enrollment in 5 months

Conditions

Postoperative Complications
Critical Illness

Treatments

Other: Presence of a risk factor

Study type

Observational

Funder types

Other

Identifiers

NCT06731296
GRIVI_2024_01_QX_UCI

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

15 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Abdominal surgery
Description:
Patients admitted to the ICU after an abdominal surgery.
Treatment:
Other: Presence of a risk factor
Older adults
Description:
Older adults (65+) surgical patients admitted to the ICU.
Treatment:
Other: Presence of a risk factor

Trial contacts and locations

2

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Central trial contact

Norton Perez, MD

Data sourced from clinicaltrials.gov

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