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Clinical Trials/NCT03927066
NCT03927066CompletedNot Applicable

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

Mayo Clinic1 site in 1 country100 target enrollmentStarted: May 12, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Blood Pressure

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Healthy Volunteer

Experimental

All Volunteers will be studied at rest and during experimental condition (lower body negative pressure)

Intervention: Assigned Interventions (Other)

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: One day of study visit

Arterial blood pressure both systolic and diastolic will be assessed prior to and during lower body negative pressure

Secondary Outcomes

  • Heart rate(One day of study visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Timothy B. Curry

Principal Investigator

Mayo Clinic

Study Sites (1)

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