WithdrawnNot Applicable

Noninvasive Monitor of Vascular Volume Fluid Shifts

Stopped: Sponsor decided to close the study.

United States0Started 2021-12-15

Plain-language 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.

Who can participate

Age range18 Years – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in cardiac cycle time intervals

Timeframe: Through study completion; 3 hours

Change in phonographic characteristics - amplitude

Timeframe: Through study completion; 3 hours

Change in phonographic characteristics - frequency

Timeframe: Through study completion; 3 hours

Trial details

NCT IDNCT05080881

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Blood Loss trials

Plain-language summary

Who can participate

Age range18 Years – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.