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 the ventilator (GE Healthcare, FRC INview software module). 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 the ventilator (GE Healthcare, Vent Calculations software module).

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 UC Health

  • Neal W Fleming, M.D., Ph.D. (ucdavis)
    Professor, Anesthesiology and Pain Medicine. Authored (or co-authored) 59 research publications.

Details

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