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

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

Study Overview

• Status: Recruiting
• Conditions: Hypovolemia; Hemodynamic Instability
• Intervention / Treatment: Diagnostic test: Lower body negative pressure

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Aymen Alian, MD; Phone Number: 203-785-2802; Email: aymen.alian@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • John B. Pierce Laboratory
      • Contact: Aymen A Alian; Phone Number: 203-785-2802; Email: aymen.alian@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 2000020057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No