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Recruiting NCT03592290

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

Observational Hypovolemia Hemodynamic Instability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lower body negative pressure.
Who it may be relevant to
Registry conditions: Hypovolemia, Hemodynamic Instability. Basic parameters: 20 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Diagnostic test Lower body negative pressure
    We will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Primary outcome measures

  • Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms. [Time frame: 2 years]
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 [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • John B. Pierce Laboratory — New Haven

Identifiers

NCT: NCT03592290 · 2000020057 · 000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗