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

NCT03927066 | Completed

• 1 other identifier: 19-002893
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension and Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart rate

  One day of study visit

Study Arms (1)

Healthy Volunteer

EXPERIMENTAL

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

Other: Assigned Interventions

Interventions

Assigned Interventions OTHER

Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.

Also known as: Lower body negative pressure

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypotension; Shock

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression; Therapeutics

Study Officials

• Timothy B Curry

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: May 12, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (1)