NCT03582501

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 hypovolemia by analyzing the arterial waveforms collected during LBNP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 26, 2018

Last Update Submit

June 11, 2019

Conditions

Hypotension and Shock

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Arterial blood pressure 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 volunteers

EXPERIMENTAL

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

Other: Lower body negative pressure

Interventions

Lower body negative pressureOTHER

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

Healthy volunteers

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year of age Non-smoker No history of hypertension No history of diabetes No history of coronary artery disease No history of neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

HypotensionShock

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DecompressionTherapeutics

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
Vice Chair, Dept of Anesthesiology and Perioperative Medicine, Primary Investigator

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 11, 2018

Study Start

January 8, 2019

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Locations

US(3)