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LBPN: Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03592290
Collaborator
(none)
80
Enrollment
1
Location
59.5
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lower body negative pressure

Detailed Description

The primary aim of this research is to identify the most robust site for monitoring hypovolemia as well as assess changes in peripheral waveforms monitored by the pulse oximeter collected from different sites (finger, ear, forehead, and nose), blood pressure, cerebral oximetry and peripheral venous pressure during gradual hypovolemia induced by lower body negative pressure (LBNP) in healthy volunteers.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Actual Study Start Date :
Nov 15, 2017
Actual Primary Completion Date :
Jan 31, 2019
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms. [2 years]

    Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data. linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.

Secondary Outcome Measures

  1. Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation [2 years]

    Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data. linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy volunteers aged 20-45 with
Exclusion Criteria:

  • Pregnant women

  • Under 20 years of age

  • Subjects with coronary artery disease, diabetes, epilepsy and hypertension

Contacts and Locations

Locations

Site City State Country Postal Code
1 John B. Pierce Laboratory New Haven Connecticut United States 06520

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Aymen Alian, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT03592290
Other Study ID Numbers:
  • 2000020057
First Posted:
Jul 19, 2018
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypovolemia

Study Results

No Results Posted as of Apr 1, 2022