Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans

Hypotension and Shock Clinical Trial

Official title:

Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927066
• Other study ID #: 19-002893
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: November 8, 2022

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypotension
• Hypotension and Shock

Intervention

Other:
• Assigned Interventions
Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials