HemorrhageNCT03671902
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
A study testing Fluid shift in people with Hemorrhage, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Fluid shift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Mar 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years old
- Good health
- Free of systemic diseases
- No contraindications to LBNP/LBPP exposure
- Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg)
Who cannot join
- Pregnancy
- Prior history of cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).
- Conditions
- Hemorrhage
- Being tested
- Fluid shift
- Keywords
- Phonocardiogram
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid shiftDevice
We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift
| Study group | Role | What they receive |
|---|---|---|
| Lower Body Negative/Positive Pressure | Other | Not described Receives: Device: Fluid shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the phonocardiographic systolic index (PSI)
Measuring changes in phonocardiographic parameters related to changes in blood volume
Measured: Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Feb 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- Jay C. Buckey, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671902
- Sponsor's protocol ID
- STUDY00030287 DF18055
- Status last verified
- Apr 2023
- First submitted
- 13 Sep 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Monitoring in Lower Body Negative and Positive Pressure Tests
- ClinicalTrials.gov ID
- NCT03671902
- Acronym / sponsor ID
- STUDY00030287 DF18055
- Conditions
- Hemorrhage
- Keywords
- Phonocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 14 Sep 2018 (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.
The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Body Negative/Positive Pressure | Other | Device: Fluid shift |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Good health
- Free of systemic diseases
- No contraindications to LBNP/LBPP exposure
- Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg)
Key exclusion criteria (2 listed)
- Pregnancy
- Prior history of cardiovascular disease
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 |
|---|---|---|
| Fluid shiftWe are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift | Device | Lower Body Negative/Positive Pressure |
Primary outcome
Change in the phonocardiographic systolic index (PSI)
Time frame: Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min
Measuring changes in phonocardiographic parameters related to changes in blood volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Jay C. Buckey, 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 Fluid shift in people with Hemorrhage, 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 5 inclusion and 2 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the phonocardiographic systolic index (PSI) (time frame: Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min). 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.