Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Physical Trauma

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01871909

13-0286

Details and patient eligibility

About

Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.

Full description

Specific aims:

1. Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
2. Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Enrollment: 50 patients

Sex: All

Ages: 31 days to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: 31 days - 89 years
• patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center
• Patients with report of physical trauma within 24 hours of presentation at the hospital.

Exclusion criteria

• pregnant patients
• incarcerated patients
• patients who object at any time to participating in the study

Trial design

50 participants in 1 patient group

Physical trauma

Description:

Patients with report of physical trauma within 24 hours of presentation to the hospital.