Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-45
SponsorYale University
About this trial
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Pregnant women
Under 20 years of age
Subjects with coronary artery disease, diabetes, epilepsy and hypertension
Trial population
Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Lower body negative pressure
Diagnostic testWe will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
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.
Time frame
2 yearsSecondary outcomes
1
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
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.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov