Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
Study Details
Study Description
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:
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Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| VQm PHM™ Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care. |
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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
Other Outcome Measures
- Shunt fraction changes due to ETT Clamping [Through completion of study, up to 72 hours]
Determining the effects of clamping the ETT on shunt fraction compared to baseline
- PBF changes due to ETT Clamping [Through completion of study, up to 72 hours]
Determining the effects of clamping the ETT on PBF compared to baseline
- FRC changes due to ETT Clamping [Through completion of study, up to 72 hours]
Determining the effects of clamping the ETT on FRC compared to baseline
- VD changes due to ETT Clamping [Through completion of study, up to 72 hours]
Determining the effects of clamping the ETT on VD compared to baseline
- Shunt fraction changes due to participant positional changes [Through completion of study, up to 72 hours]
Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (shunt fraction) compared to baseline
- PBF changes due to participant positional changes [Through completion of study, up to 72 hours]
Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (PBF) compared to baseline
- FRC changes due to participant positional changes [Through completion of study, up to 72 hours]
Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (FRC) compared to baseline
- VD changes due to participant positional changes [Through completion of study, up to 72 hours]
Determining the effects of positional changes [i.e. passive leg raise, semi-recumbent] the pulmonary health parameters (VD) compared to baseline
- Shunt fraction changes due to delivery of vasopressors [Through completion of study, up to 72 hours]
Determining the effects of vasopressor administration on the pulmonary health parameters (shunt fraction) compared to baseline
- PBF changes due to delivery of vasopressors [Through completion of study, up to 72 hours]
Determining the effects of vasopressor administration on the pulmonary health parameters (PBF) compared to baseline
- FRC changes due to delivery of vasopressors [Through completion of study, up to 72 hours]
Determining the effects of vasopressor administration on the pulmonary health parameters (FRC) compared to baseline
- VD changes due to delivery of vasopressors [Through completion of study, up to 72 hours]
Determining the effects of vasopressor administration on the pulmonary health parameters (VD) compared to baseline
- Shunt fraction changes due to progression of ARDS [Through completion of study, up to 72 hours]
Determining the effects of ARDS on the pulmonary health parameters (shunt fraction) compared to baseline
- PBF changes due to progression of ARDS [Through completion of study, up to 72 hours]
Determining the effects of ARDS on the pulmonary health parameters (PBF) compared to baseline
- FRC changes due to progression of ARDS [Through completion of study, up to 72 hours]
Determining the effects of ARDS on the pulmonary health parameters (FRC) compared to baseline
- VD changes due to progression of ARDS [Through completion of study, up to 72 hours]
Determining the effects of ARDS on the pulmonary health parameters (VD) compared to baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female 18 years old or above, at the time of the inclusion
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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
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Provision of signed and dated informed consent form (ICF) by the patient or a trusted person
Exclusion Criteria:
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Male or female under the age of 18 years old, at the time of screening
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Patient under guardianship
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Patient who requires tidal volumes of less than 250cc
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Pregnancy
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Patient whose care requires the use of an anesthetic conserving device
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Patient whose care requires a closed-loop ventilator
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Patient who is unable to tolerate a transient increase in inhaled CO2
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Patient who is unable to tolerate a transient inhalation of N2O or is contraindicated to N2O use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
| 2 | Medical University of Vienna | Vienna | Austria | 1090 | |
| 3 | University Hospital Kralovske Vinohrady | Prague | Czechia | 10034 | |
| 4 | Hôpital Européen Georges Pompidou | Paris | France | 75015 |
Sponsors and Collaborators
- Rostrum Medical Innovations Inc.
- Medical Initiatives
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LM02-CLR-0002