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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A-line/CareTaker Comparison Study in ICU Patients

NCT02479724

Blood Pressure

COMPLETED

Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation

NCT03481855

Health, Subjective

COMPLETED

Contributing Factors to Local Bioimpedance Spectroscopy

NCT06003205

Fluid and Electrolyte Imbalance Overhydration Edema

COMPLETED NA

Impedance Threshold Device Tilt Study

NCT00137319

Orthostatic Hypotension

TERMINATED NA

Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.

NCT00818233

Intraocular Pressure

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical trauma

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.