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Completed

NCT Number: NCT01871909

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

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.

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Key information

Conditions

Physical Trauma Wounds and Injuries

Age range

31 day–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

Specific aims:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Waveform data comparison

    Time frame: Up to 12 months

    Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.

  2. Approximation accuracy

    Time frame: Up to 12 months

    Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Validation of LBNP Model of Human Hemorrhage in Trauma Patients

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2013
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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