Status:
UNKNOWN
Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine
Lead Sponsor:
Rostrum Medical Innovations Inc.
Collaborating Sponsors:
University of California, Davis
Conditions:
Elective Procedures Requiring Mechanical Ventilation
Eligibility:
All Genders
18-75 years
Brief 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 ...
Detailed Description
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 (Qs...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04730063
Start Date
February 17 2021
End Date
February 1 2023
Last Update
April 27 2022
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817