Summary

Eligibility
for people ages 18-75 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Neal W Fleming, M.D., Ph.D. (ucdavis)

Description

Summary

This is a prospective, observational study to assess agreement of pulmonary health parameters measured by a new non-invasive physiologic monitor, the VQm pulmonary health monitor (PHM)™ with clinical gold standards.

Official Title

Prospective Non-Interventional Study Evaluating Non-invasive Measurements of Pulmonary Blood Flow, Functional Residual Capacity, Shunt Fraction Index and Airway Dead Space Measured With the VQm PHM™ to Clinical Gold Standards

Details

The specific aim of this study is to evaluate the intermittent non-invasive measurements of pulmonary function: pulmonary blood flow (PBF), functional residual capacity (FRC), shunt fraction index (Qsi) and airway dead space measured by the VQm PHM™ compared to known clinical standards. PBF will be compared to continuous and intermittent bolus thermodilution cardiac output as measured through a Swan-Ganz catheter. FRC will be compared to an FRC measurement provided by a standard nitrogen washout method. Qsi will be compared to shunt fraction calculated through mixed venous and arterial blood gas values (VBGs/ABGs). Airway dead space will be compared to an airway dead space measurement provided by a ventilator.

Keywords

Elective Procedures Requiring Mechanical Ventilation Physiologic Monitors Acute Care Medicine VQm PHM™

Eligibility

You can join if…

Open to people ages 18-75

  • Age greater than 18 years
  • Scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia without the use of inhalation anesthetics
  • Surgical procedure that requires pressure-controlled positive pressure ventilation using an endotracheal tube
  • Surgical procedure that requires the use of intra-arterial pressure monitoring and/or a Swan-Ganz catheter for the monitoring of continuous cardiac output

You CAN'T join if...

  • Patients who require ventilation tidal volumes less than 250cc
  • Age less than 18 years
  • Pregnancy
  • Prisoners
  • Surgical procedure which requires carbon dioxide (CO2) insufflation
  • Unable to tolerate a transient increase in inhaled CO2
  • Unable to tolerate a transient increase in inhaled nitrous oxide (N2O) or use of N2O is contraindicated
  • Patients who require a high fraction of inspired oxygen (FiO2) (>70%) to maintain a hemoglobin saturation (SpO2>98%)

Women, minorities or non-English speaking subjects will not be excluded

Location

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Neal W Fleming, M.D., Ph.D. (ucdavis)
    Professor, Anesthesiology and Pain Medicine. Authored (or co-authored) 60 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rostrum Medical Innovations Inc.
ID
NCT04730063
Study Type
Observational
Last Updated