Clinical trial NCT04730063: Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elective Procedures Requiring Mechanical Ventilation
Keywords: Physiologic Monitors
Acute Care Medicine
Lead sponsor: Rostrum Medical Innovations Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, Davis
First posted: 2021-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery requiring mechanical ventilation

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.

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 (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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Comparison of pulmonary function parameters to known clinical standards
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Director, Cardiovascular and Thoracic Anesthesiology
name: Neal W Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: