Clinical trial NCT05080881: Noninvasive Monitor of Vascular Volume Fluid Shifts
Official title: Noninvasive Monitor of Vascular Volume Fluid Shifts
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Loss
Keywords: phonocardiographic measurements
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiac cycle time intervals
timeFrame: Through study completion; 3 hours
measure: Change in phonographic characteristics - amplitude
timeFrame: Through study completion; 3 hours
measure: Change in phonographic characteristics - frequency
timeFrame: Through study completion; 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James C Leiter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: