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NCT03671902 Clinical Trial

Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests

Hemorrhage Clinical Trial

Official title:
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03671902
Other study ID # STUDY00030287 DF18055
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date March 30, 2018

Study information
Verified date April 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - At least 18 years old - Good health - Free of systemic diseases - No contraindications to LBNP/LBPP exposure - Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg) Exclusion Criteria: - Pregnancy - Prior history of cardiovascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fluid shift
We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the phonocardiographic systolic index (PSI) Measuring changes in phonocardiographic parameters related to changes in blood volume Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min
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