HypovolemiaLBPNNCT03592290
Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
An observational study of Hypovolemia and Hemodynamic Instability, run by Yale University at 1 site in United States.
Trial summary
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia, Hemodynamic Instability
- What is being tested?
- Lower body negative pressure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.
Who may be able to join
- Healthy volunteers aged 20-45 with
Who cannot join
- Pregnant women
- Under 20 years of age
- Subjects with coronary artery disease, diabetes, epilepsy and hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
John B. Pierce Laboratory
New Haven, Connecticut, 06520
Aymen A Alian, 203-785-2802, aymen.alian@yale.edu
About this study
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Read the detailed description
The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.
- Conditions
- Hypovolemia, Hemodynamic Instability
- Being tested
- Lower body negative pressure
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body negative pressureDiagnostic test
We will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data.
linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.
Measured: 2 years
Secondary outcomes (1)
Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation
Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data.
linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Nov 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymen Alian, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592290
- Sponsor's protocol ID
- 2000020057
- Other IDs
- 000
- Acronym
- LBPN
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2018
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
- ClinicalTrials.gov ID
- NCT03592290
- Acronym / sponsor ID
- LBPN / 2000020057
- Conditions
- Hypovolemia, Hemodynamic Instability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Jul 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.
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Detailed description
The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.
Key inclusion criteria (1 listed)
- Healthy volunteers aged 20-45 with
Key exclusion criteria (3 listed)
- Pregnant women
- Under 20 years of age
- Subjects with coronary artery disease, diabetes, epilepsy and hypertension
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 |
|---|---|---|
| Lower body negative pressureWe will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers. | Diagnostic test | – |
Primary outcome
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.
Time frame: 2 years
Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data. linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.
1 secondary outcome
Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Related trials for Hypovolemia
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
RecruitingPhase 4
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Hypovolemic Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
Dehydration, Hypovolemia
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.
Aymen Alian, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia and Hemodynamic Instability, run by Yale University 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 1 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aymen Alian, MD (203-785-2802, aymen.alian@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms. (time frame: 2 years). 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 20 Jan 2026.