Blood LossNCT05080881
Noninvasive Monitor of Vascular Volume Fluid Shifts
A study testing phonocardiographic measurement: InnoVital Systems, phonocardiographic measurement: ThinkLabs StethOne and physiological measurements: BIOPAC in people with Blood Loss, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- phonocardiographic measurement: InnoVital Systems, phonocardiographic measurement: ThinkLabs StethOne and physiological measurements: BIOPAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- In generally good health
Show all 12Show fewer
- 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)
Who cannot join
- 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:
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Blood Loss
- Being tested
- phonocardiographic measurement: InnoVital Systems, phonocardiographic measurement: ThinkLabs StethOne, physiological measurements: BIOPAC, physiological measurements: Masimo Radical-7, physiological measurements: CoVa Monitoring System 2
- Keywords
- phonocardiographic measurements
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonocardiographic measurement: InnoVital SystemsDiagnostic test
Also called 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.
phonocardiographic measurement: ThinkLabs StethOneDiagnostic test
Also called 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.
physiological measurements: BIOPACDiagnostic test
Also called 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.
physiological measurements: Masimo Radical-7Diagnostic test
Also called Masimo Radical-7
A commercially available device for pulse oximetry and continuous non-invasive hematocrit measurement.
physiological measurements: CoVa Monitoring System 2Diagnostic test
Also called 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.
Thoracic impedanceDiagnostic test
Also called Baxter
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac cycle time intervals
Cardiac systolic and diastolic times
Measured: Through study completion; 3 hours
Change in phonographic characteristics - amplitude
Size of cardiac systolic and diastolic heart tones
Measured: Through study completion; 3 hours
Change in phonographic characteristics - frequency
Frequency content of cardiac tones
Measured: Through study completion; 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Sponsor decided to close the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C. Leiter, Dartmouth-Hitchcock Medical Center
- Investigators
- James C Leiter, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080881
- Sponsor's protocol ID
- D18144
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no data to share.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Monitor of Vascular Volume Fluid Shifts
- ClinicalTrials.gov ID
- NCT05080881
- Acronym / sponsor ID
- D18144
- Conditions
- Blood Loss
- Keywords
- phonocardiographic measurements
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to close the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw | Experimental | 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 impedanceAll 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phonocardiographic measurement: InnoVital SystemsAlso: InnoVital SystemsThe 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. | Diagnostic test | Blood draw |
| phonocardiographic measurement: ThinkLabs StethOneAlso: ThinkLabs StethOneThis 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. | Diagnostic test | Blood draw |
| physiological measurements: BIOPACAlso: BIOPACNon-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. | Diagnostic test | Blood draw |
| physiological measurements: Masimo Radical-7Also: Masimo Radical-7A commercially available device for pulse oximetry and continuous non-invasive hematocrit measurement. | Diagnostic test | Blood draw |
| physiological measurements: CoVa Monitoring System 2Also: CoVa Monitoring System 2This 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. | Diagnostic test | Blood draw |
| Thoracic impedanceAlso: BaxterThoracic 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). | Diagnostic test | Blood draw |
Primary outcome
Change in cardiac cycle time intervals
Time frame: Through study completion; 3 hours
Cardiac systolic and diastolic times
Change in phonographic characteristics - amplitude
Time frame: Through study completion; 3 hours
Size of cardiac systolic and diastolic heart tones
Change in phonographic characteristics - frequency
Time frame: Through study completion; 3 hours
Frequency content of cardiac tones
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No. There are no data to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Leiter, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phonocardiographic measurement: InnoVital Systems, phonocardiographic measurement: ThinkLabs StethOne and physiological measurements: BIOPAC in people with Blood Loss, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac cycle time intervals (time frame: Through study completion; 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.