Back to resultsNoninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Primary Purpose
Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid shift
Sponsored by
About this trial
This is an interventional diagnostic trial for Hemorrhage focused on measuring Phonocardiogram
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lower Body Negative/Positive Pressure
Arm Description
Outcomes
Primary Outcome Measures
Change in the phonocardiographic systolic index (PSI)
Measuring changes in phonocardiographic parameters related to changes in blood volume
Secondary Outcome Measures
Full Information
NCT ID
NCT03671902
First Posted
September 13, 2018
Last Updated
April 21, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03671902
Brief Title
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Official Title
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Phonocardiogram
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower Body Negative/Positive Pressure
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Fluid shift
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the phonocardiographic systolic index (PSI)
Description
Measuring changes in phonocardiographic parameters related to changes in blood volume
Time Frame
Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay C. Buckey, M.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
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