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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927066
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy B. Curry, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Hypotension and Shock Other: Assigned Interventions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : October 10, 2023
Estimated Study Completion Date : October 10, 2023

Arm Intervention/treatment
Experimental: Healthy Volunteer
All Volunteers will be studied at rest and during experimental condition (lower body negative pressure)
Other: Assigned Interventions
Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
Other Name: Lower body negative pressure




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Heart rate [ Time Frame: One day of study visit ]
    Heart rate prior to and during lower body negative pressure



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927066


Contacts
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Contact: Pamela A Engrav 507-255-6938 engrav.pamela@mayo.edu
Contact: Timothy B Curry, M.D.

Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Contact: Pamela A Engrav    507-255-6938    engrav.pamela@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Timothy B Curry Mayo Clinic
Additional Information:
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Responsible Party: Timothy B. Curry, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03927066    
Other Study ID Numbers: 19-002893
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases