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

Completed

• Conditions: Physical Trauma

• Registration Number: NCT01871909
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Study Start: 2013-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Approximation accuracy	Up to 12 months	Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
Waveform data comparison	Up to 12 months	Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.

Trial Locations

Locations (3)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

San Antonio Military Medical Center; 🇺🇸 San Antonio, Texas, United States