Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Rostrum Medical Innovations Inc.150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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