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

Hemodynamic Instability Clinical Trial

— LBPN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592290
• Other study ID #: 2000020057
• Status: Recruiting
• Start date: November 15, 2017
• Est. completion date: February 2024

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: Aymen Alian, MD
• Phone: 203-785-2802
• Email: aymen.alian[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2024
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Hypovolemia

Intervention

Diagnostic Test:
• Lower 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.

Locations

Country	Name	City	State
United States	John B. Pierce Laboratory	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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