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NCT Number: NCT03592290

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

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

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Key information

Conditions

Hypovolemia Hemodynamic Instability Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John B. Pierce Laboratory

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Location contact

Aymen A Alian

CONTACT

[email protected]

203-785-2802

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower body negative pressure

Diagnostic Test

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

Primary outcomes

  1. 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

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aymen Alian, MD

CONTACT

[email protected]

203-785-2802

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: LBPN

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2018
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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