Trials / Unknown
UnknownNCT06147674
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Rostrum Medical Innovations Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ventilators, Mechanical
- Stroke
- COPD
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- Pneumonia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VQm Pulmonary Health Monitor™ | 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) |
Timeline
- Start date
- 2024-01-15
- Primary completion
- 2025-01-15
- Completion
- 2025-03-31
- First posted
- 2023-11-27
- Last updated
- 2023-11-27
Locations
4 sites across 4 countries: United States, Austria, Czechia, France
Source: ClinicalTrials.gov record NCT06147674. Inclusion in this directory is not an endorsement.