Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
- Conditions
- COPDAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)PneumoniaVentilators, MechanicalStroke
- Interventions
- Device: VQm Pulmonary Health Monitor™
- Registration Number
- NCT06147674
- Lead Sponsor
- Rostrum Medical Innovations Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VQm PHM™ VQm Pulmonary Health Monitor™ Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care.
- Primary Outcome Measures
Name Time Method Shunt fraction value Through study completion, an average of 12 months Confirming the performance of non-invasive pulmonary health parameter shunt value found on the VQm PHM™ monitor when compared to available reference measurements
- Secondary Outcome Measures
Name Time Method Pulmonary blood flow - trend Through study completion, an average of 12 months Confirming the performance of non-invasive pulmonary health parameter PBF trend found on the VQm PHM™ monitor when compared to available reference measurements
High pressure due to volume control (safety) Through completion of study, up to 72 hours 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.
Functional residual capacity - trend Through study completion, an average of 12 months Confirming the performance of non-invasive pulmonary health parameter FRC trend found on the VQm PHM™ monitor when compared to available reference measurements
Incident rate of adverse events, adverse events and treatment-emergent serious adverse events Through completion of study, up to 72 hours As deemed caused by the the VQm PHM™ monitor during standard of care in the ICU setting.
Safe range of nitrous oxide delivery (safety) Through completion of study, up to 72 hours Confirming the acceptable safety limitations of nitrous oxide gas delivery by the VQm PHM™ monitor below 10% as measured by the device.
Pulmonary blood flow - absolute value Through study completion, an average of 12 months Confirming the performance of non-invasive pulmonary health parameter PBF absolute values found on the VQm PHM™ monitor when compared to available reference measurements
Oxygen desaturation due to breathing circuit connectivity (safety) Through completion of study, up to 72 horus 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.
Functional residual capacity - absolute value Through study completion, an average of 12 months Confirming the performance of non-invasive pulmonary health parameter FRC absolute values found on the VQm PHM™ monitor when compared to available reference measurements
High volume due to pressure control (safety) Through completion of study, up to 72 hours 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.
Physiological dead space Through study completion, an average of 12 months 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
Trial Locations
- Locations (4)
Medical University of Vienna
🇦🇹Vienna, Austria
University Hospital Kralovske Vinohrady
🇨🇿Prague, Czechia
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
UC Davis Medical Center
🇺🇸Sacramento, California, United States