Hypotension and Shock Clinical Trial
Official title:
Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
NCT number | NCT03927066 |
Other study ID # | 19-002893 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 12, 2021 |
Est. completion date | November 8, 2022 |
Verified date | May 2023 |
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 hyporvolemia by analyzing the arterial waveforms collected during LBNP.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 8, 2022 |
Est. primary completion date | November 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Non-obese (BMI < 30) - Non-smokers - Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity - Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Pressure | Arterial blood pressure both systolic and diastolic will be assessed 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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