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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03592290
Other study ID # 2000020057
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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