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

Recruiting

• Conditions: Hemodynamic Instability; Hypovolemia

• Registration Number: NCT03592290
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

* Healthy volunteers aged 20-45 with

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

John B. Pierce Laboratory; 🇺🇸 New Haven, Connecticut, United States