Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Elective Procedures Requiring Mechanical Ventilation

Intervention / Treatment
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* Device: VQm PHM™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VQm PHM™|Procedure: Non-invasive measurements obtained with the VQm PHM™|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiologic Monitors, Acute Care Medicine