Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine
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
1 other identifier
observational
40
1 country
1
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 gold standards.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedStudy Start
First participant enrolled
February 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedApril 27, 2022
April 1, 2022
1.9 years
January 25, 2021
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of pulmonary function parameters to known clinical standards
Assess agreement between measurements from VQm PHM™ to clinical gold standards
Through study completion, an average of 12 months
Interventions
Procedure: Non-invasive measurements obtained with the VQm PHM™
Eligibility Criteria
Patients scheduled for elective surgery requiring mechanical ventilation
You may qualify if:
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rostrum Medical Innovations Inc.lead
- University of California, Daviscollaborator
Study Sites (1)
UC Davis Medical Center
Sacramento, California, 95817, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Neal W Fleming, M.D., Ph.D.
Director, Cardiovascular and Thoracic Anesthesiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 29, 2021
Study Start
February 17, 2021
Primary Completion
January 1, 2023
Study Completion
February 1, 2023
Last Updated
April 27, 2022
Record last verified: 2022-04