Noninvasive Monitor of Vascular Volume Fluid Shifts

NCT05080881 | Withdrawn

• 1 other identifier: D18144
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Loss

Keywords

phonocardiographic measurements

Outcome Measures

Primary Outcomes (3)

• Change in cardiac cycle time intervals

  Cardiac systolic and diastolic times

  Through study completion; 3 hours

• Change in phonographic characteristics - amplitude

  Size of cardiac systolic and diastolic heart tones

  Through study completion; 3 hours

• Change in phonographic characteristics - frequency

  Frequency content of cardiac tones

  Through study completion; 3 hours

Study Arms (1)

Blood draw

EXPERIMENTAL

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; Diagnostic Test: phonocardiographic measurement: ThinkLabs StethOne; Diagnostic Test: physiological measurements: BIOPAC; Diagnostic Test: physiological measurements: Masimo Radical-7; Diagnostic Test: physiological measurements: CoVa Monitoring System 2; Diagnostic Test: Thoracic impedance

Interventions

phonocardiographic measurement: InnoVital Systems DIAGNOSTIC_TEST

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.

Also known as: InnoVital Systems

Blood draw

phonocardiographic measurement: ThinkLabs StethOne DIAGNOSTIC_TEST

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.

Also known as: ThinkLabs StethOne

Blood draw

physiological measurements: BIOPAC DIAGNOSTIC_TEST

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.

Also known as: BIOPAC

Blood draw

physiological measurements: Masimo Radical-7 DIAGNOSTIC_TEST

A commercially available device for pulse oximetry and continuous non-invasive hematocrit measurement.

Also known as: Masimo Radical-7

Blood draw

physiological measurements: CoVa Monitoring System 2 DIAGNOSTIC_TEST

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.

Also known as: CoVa Monitoring System 2

Blood draw

Thoracic impedance DIAGNOSTIC_TEST

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).

Also known as: Baxter

Blood draw

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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)
• Pregnancy

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Cardiography, Impedance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography, Impedance; Plethysmography

Study Officials

• James C Leiter, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Molecular and Systems Biology

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 18, 2021
• Study Start: December 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)