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

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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

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date September 25, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date October 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Blood Pressure [ Time Frame: One day of study visit ]
Arterial blood pressure prior to and during lower body negative pressure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Heart rate [ Time Frame: One day of study visit ]
Heart rate prior to and during lower body negative pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Official Title  ICMJE Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hypotension and Shock
Intervention  ICMJE Other: Assigned Interventions
Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
Other Name: Lower body negative pressure
Study Arms  ICMJE Experimental: Healthy Volunteer
All Volunteers will be studied at rest and during experimental condition (lower body negative pressure)
Intervention: Other: Assigned Interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 10, 2023
Estimated Primary Completion Date October 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pamela A Engrav 507-255-6938 engrav.pamela@mayo.edu
Contact: Timothy B Curry, M.D.
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927066
Other Study ID Numbers  ICMJE 19-002893
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy B. Curry, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy B Curry Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP