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

Validation of LBNP Model of Human Hemorrhage in Trauma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01871909

Enrollment

Registered

2013-06-07

Start date

2013-10-31

Completion date

2018-12-31

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Trauma

Keywords

Physical trauma

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

31 Days to 89 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

United States

Outcome results