Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical Initiatives | NETWORK |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VQm PHM™ | Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VQm Pulmonary Health Monitor™ | Device | 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:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shunt fraction changes due to ETT Clamping | Determining the effects of clamping the ETT on shunt fraction compared to baseline | Through completion of study, up to 72 hours |
| PBF changes due to ETT Clamping |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients currently admitted to the ICUs requiring mechanical ventilation will be screened for potential enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan Ayoubi | Contact | 604-439-3054 | nathan@rostrummedical.com | |
| Scott Alexander, MBBS | Contact | scott.alexander@rostrummedical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D011014 | Pneumonia |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
Determining the effects of clamping the ETT on PBF compared to baseline
| Through completion of study, up to 72 hours |
| FRC changes due to ETT Clamping | Determining the effects of clamping the ETT on FRC compared to baseline | Through completion of study, up to 72 hours |
| VD changes due to ETT Clamping | Determining the effects of clamping the ETT on VD compared to baseline | Through completion of study, up to 72 hours |
| Shunt fraction changes due to participant positional changes | Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (shunt fraction) compared to baseline | Through completion of study, up to 72 hours |
| PBF changes due to participant positional changes | Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (PBF) compared to baseline | Through completion of study, up to 72 hours |
| FRC changes due to participant positional changes | Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (FRC) compared to baseline | Through completion of study, up to 72 hours |
| VD changes due to participant positional changes | Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (VD) compared to baseline | Through completion of study, up to 72 hours |
| Shunt fraction changes due to delivery of vasopressors | Determining the effects of vasopressor administration on the pulmonary health parameters (shunt fraction) compared to baseline | Through completion of study, up to 72 hours |
| PBF changes due to delivery of vasopressors | Determining the effects of vasopressor administration on the pulmonary health parameters (PBF) compared to baseline | Through completion of study, up to 72 hours |
| FRC changes due to delivery of vasopressors | Determining the effects of vasopressor administration on the pulmonary health parameters (FRC) compared to baseline | Through completion of study, up to 72 hours |
| VD changes due to delivery of vasopressors | Determining the effects of vasopressor administration on the pulmonary health parameters (VD) compared to baseline | Through completion of study, up to 72 hours |
| Shunt fraction changes due to progression of ARDS | Determining the effects of ARDS on the pulmonary health parameters (shunt fraction) compared to baseline | Through completion of study, up to 72 hours |
| PBF changes due to progression of ARDS | Determining the effects of ARDS on the pulmonary health parameters (PBF) compared to baseline | Through completion of study, up to 72 hours |
| FRC changes due to progression of ARDS | Determining the effects of ARDS on the pulmonary health parameters (FRC) compared to baseline | Through completion of study, up to 72 hours |
| VD changes due to progression of ARDS | Determining the effects of ARDS on the pulmonary health parameters (VD) compared to baseline | Through completion of study, up to 72 hours |
| Medical University of Vienna | Vienna | 1090 | Austria |
|
| University Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |