Hypotension and Shock Clinical Trial
— LBNPOfficial title:
Physiology of the Early Stage of Hemorrhage and Early Identification of Progression Toward Hemodynamic Instability in Humans for Validation of Current Machine Learning Models
NCT number | NCT03582501 |
Other study ID # | 18-002695 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 8, 2019 |
Est. completion date | May 23, 2019 |
Verified date | June 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hypovolemia by analyzing the arterial waveforms collected during LBNP.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 23, 2019 |
Est. primary completion date | May 23, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion criteria: 18-55 year of age Non-smoker No history of hypertension No history of diabetes No history of coronary artery disease No history of neurologic disease Exclusion criteria Prescribed medications other than birth control Inability to lie flat for two hours BMI > 30 kg/m2 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure | Arterial blood pressure prior to and during lower body negative pressure | One day of study visit | |
Secondary | Heart rate | Heart rate prior to and during lower body negative pressure | One day of study visit |
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