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RecruitingNCT03592290LBPNUpdated Jan 20, 2026

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

An observational study in Hypovolemia and Hemodynamic Instability, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Yale University · Observational

From the registry’s dates

  • Started Nov 2017; still recruiting 8 years 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
20 Years to 45 Years
Sex
All
01

Study summary

To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Read the 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.

02

Conditions studied

  • Hypovolemia
  • Hemodynamic Instability

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03

In context

Hypovolemia

133 studies on the registry are indexed under Hypovolemia; 19 are open to participants now.

This study's planned enrollment of 120 is above the median of 52 across 63 observational studies indexed under Hypovolemia.

Browse Hypovolemia studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.

Inclusion criteria

* Healthy volunteers aged 20-45 with

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Under 20 years of age
  • Subjects with coronary artery disease, diabetes, epilepsy and hypertension
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

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.

06

What researchers measure

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 years

Secondary 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 years

07

Study locations

1 of 1 sites recruiting
  • John B. Pierce Laboratory
    New Haven, Connecticut 06520, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03592290
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Nov 15, 2017
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 20, 2026

Study contacts

Aymen Alian, MD
Contact
aymen.alian@yale.edu
203-785-2802
Aymen Alian, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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