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

Primary Purpose

Hypotension and Shock

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypotension and Shock

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Volunteer

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
Heart rate prior to and during lower body negative pressure

Full Information

First Posted
April 22, 2019
Last Updated
May 30, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03927066
Brief Title
Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Official Title
Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension and Shock

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteer
Arm Type
Experimental
Arm Description
All Volunteers will be studied at rest and during experimental condition (lower body negative pressure)
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Other Intervention Name(s)
Lower body negative pressure
Intervention Description
Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Arterial blood pressure both systolic and diastolic will be assessed prior to and during lower body negative pressure
Time Frame
One day of study visit
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate prior to and during lower body negative pressure
Time Frame
One day of study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Curry
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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