Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yale University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
Study Overview
Brief Summary
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Detailed Description
The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •* Healthy volunteers aged 20-45 with
Exclusion Criteria
- •Pregnant women
- •Under 20 years of age
- •Subjects with coronary artery disease, diabetes, epilepsy and hypertension
Outcomes
Primary Outcomes
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
Time Frame: 2 years
Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data. linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.
Secondary Outcomes
- Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation(2 years)