Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Study Overview
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Brief Summary
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The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are: Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements. Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.

Detailed Description
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This is a multi-site, international, prospective, non-blinded, non-randomized, observational study. This study aims to compare measurements from the VQm PHM™ to existing clinical measurements, assess safety of the device and determine effects that standard clinical events have on the VQm PHM™ measurements. This study does not include changes to clinical care based on measurements from the VQm PHM™. Each patient will serve as their own control.

Official Title
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Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine

Conditions
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Ventilators, Mechanical, Stroke, COPD, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Pneumonia

Intervention / Treatment
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* Device: VQm Pulmonary Health Monitor™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years old or above, at the time of the inclusion Patient currently admitted in the ICU, who are indicated for cardiac output monitoring using a pulmonary artery catheter and who require pressure or volume controlled mechanical ventilation using an ETT Provision of signed and dated informed consent form (ICF) by the patient or a trusted person Exclusion Criteria: Male or female under the age of 18 years old, at the time of screening Patient under guardianship Patient who requires tidal volumes of less than 250cc Pregnancy Patient whose care requires the use of an anesthetic conserving device Patient whose care requires a closed-loop ventilator Patient who is unable to tolerate a transient increase in inhaled CO2 Patient who is unable to tolerate a transient inhalation of N2O or is contraindicated to N2O use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VQm PHM™<br>Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care. | Device: VQm Pulmonary Health Monitor™<br>* The VQm Pulmonary Health Monitor™ (may be referred to as the VQm PHM™) is a a Class IIa, Health Canada approved medical device used as an adjunct monitor and is non-life supporting, providing clinicians with measurements of pulmonary function parameters of mechanically ventilated adult patients. The measurements provided are: Pulmonary Blood Flow (PBF) Shunt Fraction (Qsi) Dead space (VD): Functional Residual Capacity (FRC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shunt fraction value | Confirming the performance of non-invasive pulmonary health parameter shunt value found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary blood flow - trend | Confirming the performance of non-invasive pulmonary health parameter PBF trend found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 
| Functional residual capacity - trend | Confirming the performance of non-invasive pulmonary health parameter FRC trend found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 
| Pulmonary blood flow - absolute value | Confirming the performance of non-invasive pulmonary health parameter PBF absolute values found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 
| Functional residual capacity - absolute value | Confirming the performance of non-invasive pulmonary health parameter FRC absolute values found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 
| Physiological dead space | Confirming the performance of non-invasive pulmonary health parameter physiological dead space value found on the VQm PHM™ monitor when compared to available reference measurements | Through study completion, an average of 12 months | 
| Oxygen desaturation due to breathing circuit connectivity (safety) | Number of participants with treatment-related adverse events due to faulty connecting the breathing circuit during normal operation the VQm PHM™ monitor as measured by oxygen saturation desaturations of SpO2 <89% for >14s. | Through completion of study, up to 72 horus | 
| High pressure due to volume control (safety) | Number of participants with device-related adverse events due to increased pressure induced by volume-control mode as determined by peak pressure >10cm H2O ventilator setting. | Through completion of study, up to 72 hours | 
| High volume due to pressure control (safety) | Number of participants with device-related adverse events due to increased volume induced by pressure-control mode as determined by a volume >200mL from target volume. | Through completion of study, up to 72 hours | 
| Safe range of nitrous oxide delivery (safety) | Confirming the acceptable safety limitations of nitrous oxide gas delivery by the VQm PHM™ monitor below 10% as measured by the device. | Through completion of study, up to 72 hours | 
| Incident rate of adverse events, adverse events and treatment-emergent serious adverse events | As deemed caused by the the VQm PHM™ monitor during standard of care in the ICU setting. | Through completion of study, up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilation, ICU, Cardiopulmonary health