Hemodynamic Instability Clinical Trial
— LBPNOfficial title:
Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
NCT number | NCT03592290 |
Other study ID # | 2000020057 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2017 |
Est. completion date | February 2024 |
Verified date | March 2023 |
Source | Yale University |
Contact | Aymen Alian, MD |
Phone | 203-785-2802 |
aymen.alian[@]yale.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | February 2024 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: * Healthy volunteers aged 20-45 with Exclusion Criteria: - Pregnant women - Under 20 years of age - Subjects with coronary artery disease, diabetes, epilepsy and hypertension |
Country | Name | City | State |
---|---|---|---|
United States | John B. Pierce Laboratory | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
2 years | |
Secondary | 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. |
2 years |
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