Noninvasive Monitor of Vascular Volume Fluid Shifts

April 21, 2023 updated by: James C. Leiter, Dartmouth-Hitchcock Medical Center
Blood volume measurements are a critical step in the emergency care of trauma patients. The typical approach to this is to rely on historical information, physical examination and metrics such as heart rate. There is currently no good real-time measure to track blood volume. This study investigates the use of phonocardiography (listening to the sounds made by the heart) to track changes in central blood volume.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Blood draw subjects:

Participation in this study group may last up to 60 minutes. Participants will begin with a brief medical exam to determine eligibility. This will include a review of any history of cardiovascular disease and of medications. Prior to a scheduled blood draw, eligible participates will have physiological measurements taken, which may include phonocardiographic measurements, cardiac output, plethysmography (volume changes), multifrequency bioimpedance, thoracic impedance, heart rate, blood pressure, pulse oximetry, continuous non-invasive hematocrit measurement, and respiration. The phonocardiographic measurements may be taken with both a commercial and a custom-built device. These are all non-invasive measurements. After 15 minutes of baseline measurements, a blood draw will proceed normally while the physiological measurements continue. After the participant is finished donating blood, the participant will be asked to stay in place for an additional 15 minutes to continue to collect physiological data. Participants are asked not to eat or drink during the 15 minutes as this will provide better data collection. The information collected as data for this study includes: information about medical history, body measurements, and physiological measurements.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Lower Body Negative Pressure (LBNP) participants:

Inclusion Criteria:

  • In generally good health
  • Free of systemic diseases
  • No contraindications to LBNP exposure.
  • No prior history of cardiovascular disease
  • Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg).

Exclusion Criteria:

  • Individuals who, after lying supine for five minutes, show a greater than 10 mm Hg drop in systolic pressure or a greater than 20 beats/minute increase in heart rate with standing during pre-enrollment evaluation

Blood draw participants:

Inclusion Criteria:

  • In generally good health
  • Free of systemic diseases
  • No current or prior history of cardiovascular disease or cardiovascular reactive drugs
  • Blood donors through the DHMC blood donation center
  • Healthy volunteers
  • People who are taking part in another study where about 500 ml of blood is being drawn
  • Therapeutic phlebotomy patients (hemochromatosis or polycythemia vera patients)

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood draw
All blood draw subjects will have baseline data collected over 15 minutes. The participants with then donate blood. For 15 minutes after the blood donation, the participant will stay in place and will continue to have data collected.
Diagnostic test: phonocardiographic measurement: InnoVital Systems
The instrument consists of one or more low-profile microphones in plastic housings with nitrile or silicon diaphragms. These sensors convert heart sounds into analog signals that will be acquired by the BIOPAC data acquisition system.
Other Names:
  • InnoVital Systems
Diagnostic test: phonocardiographic measurement: ThinkLabs StethOne
This device senses heart sounds and may be listened to using headphones and converted to an analog signal and saved using the BIOPAC data acquisition system.
Other Names:
  • ThinkLabs StethOne
Diagnostic test: physiological measurements: BIOPAC
Non-invasive blood pressure, electrocardiogram, heart rate, respiratory rate, and leg circumference - This is a commercially available device used regularly in health care settings to monitor continual blood pressure and heart rate.
Other Names:
  • BIOPAC
Diagnostic test: physiological measurements: Masimo Radical-7
A commercially available device for pulse oximetry and continuous non-invasive hematocrit measurement.
Other Names:
  • Masimo Radical-7
Diagnostic test: physiological measurements: CoVa Monitoring System 2
This device will be used for thoracic bioimpedance and other physiological measures. This is a commercially available device. It also measures ECG, heart rate, heart rate variability, estimated stroke volume, and estimated cardiac output. The study team may measure either while body bioimpedance or thoracic bioimpedance.
Other Names:
  • CoVa Monitoring System 2
Diagnostic test: Thoracic impedance
Thoracic impedance is measured using the Starling device (https://usstarling.baxter.com/starling-system). Baxter uses a series of proprietary algorithms to infer stroke volume and cardiac output from thoracis impedance. Calculated values will be recorded, but the main variable that will be recorded is simply the temporal profile of thoracic impedance during the manipulations in each group (changing lower body negative pressure or therapeutic phlebotomy).
Other Names:
  • Baxter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiac cycle time intervals
Time Frame: Through study completion; 3 hours
Cardiac systolic and diastolic times
Through study completion; 3 hours
Change in phonographic characteristics - amplitude
Time Frame: Through study completion; 3 hours
Size of cardiac systolic and diastolic heart tones
Through study completion; 3 hours
Change in phonographic characteristics - frequency
Time Frame: Through study completion; 3 hours
Frequency content of cardiac tones
Through study completion; 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: James C Leiter, M.D., Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D18144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no data to share.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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