TRaVi: Trauma Registry in Villavicencio, Colombia

Sponsor

Hospital Departamental de Villavicencio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954936

Collaborator

Cooperative University of Colombia (Other)

150

Enrollment

Location

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Introduction: Injuries are a leading cause of mortality worldwide. It is necessary to know the incidence of injuries, mechanisms of wounds, therapy provided, and outcomes. Trauma registries are useful to describe the population served in specialized centers. Nevertheless, it is necessary also to identify the peculiarities of the event in the province and institutions non-dedicated to trauma attention.

Objective: The study aims to describe the initial experience with a trauma register in a general hospital in the Colombian Orinoquia.

Methodology: The investigators designed an observational retrospective study to analyze the admission database and revision of history charts of patients older than 15 years admitted for trauma from January to June 2023 in a hospital from Villavicencio, Colombia. The information will be exported to Excel for debugging and analysis. A description of the frequency and proportion of categorical variables will be performed; the central distribution and dispersion of quantitative variables will be reported. U of Mann-Whitney and Chi-square tests will be used to compare the variables by outcome; a p<0.05 was selected as a significant value.

Conclusions: It will be a pioneer study in this region, and it is necessary to evaluate the incidence of patients admitted by trauma, the mechanisms and type of injury, the care provided, and the outcomes.

Condition or Disease	Intervention/Treatment	Phase
Trauma Trauma Blunt Penetrating Wounds Severe Trauma Polytrauma Registries	Other: Risk factor

Detailed Description

Trauma is a leading cause of global mortality or incapacitation in survivors. The population involved is mainly young adult men affected by preventable injuries. Knowing the incidence of injuries, mechanisms of wounds, approaching strategies, and outcomes is essential to review individual interventions and collective policies to improve prevention.

Casualties in Colombia had a high incidence in previous decades; injuries and attributable deaths have recently decreased, but they are still the third cause of mortality. Contrary to high-income countries, interpersonal violence is the predominant mechanism involved.

Data registries are used worldwide in specialized centers that focus on providing healthcare in trauma. Nevertheless, it is necessary also to know the incidence in community and non-dedicated general hospitals.

Determining the characteristics of patients admitted to the emergency ward by injuries will provide essential information on the severity, mechanisms, type of population affected, immediate or consequential care delivered, and outcomes. Such an analysis will give knowledge to prioritize policies, resources, upgrade clinical practice guidelines, and improve results.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Trauma Registry in a General Hospital From Villavicencio, Colombia, First Semester 2023: An Observational Retrospective Trial

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Blunt injury Patients with non-penetrating injuries from falls, car accidents, or other mechanisms. Injuries that were caused by impact with a blunt object where there is no penetration of the skin.	Other: Risk factor No therapeutic or diagnostic intervention will be provided; it is an observational study.
Penetrating injury Penetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin.	Other: Risk factor No therapeutic or diagnostic intervention will be provided; it is an observational study.

Arm

Intervention/Treatment

Blunt injury

Patients with non-penetrating injuries from falls, car accidents, or other mechanisms. Injuries that were caused by impact with a blunt object where there is no penetration of the skin.

Other: Risk factor

No therapeutic or diagnostic intervention will be provided; it is an observational study.

Penetrating injury

Penetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin.

Other: Risk factor

No therapeutic or diagnostic intervention will be provided; it is an observational study.

Outcome Measures

Primary Outcome Measures

Number of patients dead [28 days or discharge]
Mortality on discharge or the first 28 days of hospitalization

Secondary Outcome Measures

Number of days in hospitalization [28 days or discharge]
Hospital length of stay
Number of patients needing ICU [28 days or discharge]
Need of ICU
Number of days in ICU [28 days or discharge]
ICU length of stay
Number of patients needing mechanical ventilation [28 days or discharge]
Need of mechanical ventilation
Number of days in mechanical ventilation [28 days or discharge]
Length of mechanical ventilation