Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03592290

Acronym

LBPN

Enrollment

120

Registered

2018-07-19

Start date

2017-11-15

Completion date

2027-01-01

Last updated

2026-01-20

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

Conditions

Hypovolemia, Hemodynamic Instability

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.

Interventions

DIAGNOSTIC_TESTLower body negative pressure

We will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.	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

Measure	Time frame	Description
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	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.

Countries

United States

Contacts

CONTACTAymen Alian, MD

aymen.alian@yale.edu203-785-2802

PRINCIPAL_INVESTIGATORAymen Alian, MD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026