Ventilators, MechanicalNCT06147674
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
An observational study of Ventilators, Mechanical and Stroke, run by Rostrum Medical Innovations Inc. at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilators, Mechanical, Stroke, COPD
- What is being tested?
- VQm Pulmonary Health Monitor™
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Jan 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients currently admitted to the ICUs requiring mechanical ventilation will be screened for potential enrollment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
Scott Alexander, MBBS contact
4 sites in 4 countries
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
Neal W Flemming, M.D., Ph.D., 916-734-5394, nwfleming@ucdavis.edu
Austria1 site
Medical University of Vienna
Vienna, 1090
Maximilian Edlinger-Stanger, M.D., +43 1 4016056515, maximilian.edlingerstanger@meduniwien.ac.at
Czechia1 site
University Hospital Kralovske Vinohrady
Prague, 10034
Frantisek Duska, M.D., +421 2/671 637 78, Frantisek.duska@lf3.cuni.cz
France1 site
Hôpital Européen Georges Pompidou
Paris, 75015
Bernard P Cholley, M.D., Ph.D., +33 1 56 09 20 00, bernard.cholley@aphp.fr
About this study
Official title: Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
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.
Read the 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
- Being tested
- VQm Pulmonary Health Monitor™
- Keywords
- Ventilation, ICU, Cardiopulmonary health
- Medical subject headings
- Stroke, Pulmonary Disease, Chronic Obstructive, Acute Lung Injury, Respiratory Distress Syndrome, Pneumonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Pulmonary Blood Flow (PBF)
- Shunt Fraction (Qsi)
- Dead space (VD):
- Functional Residual Capacity (FRC)
| Study group | Role | What they receive |
|---|---|---|
| VQm PHM™ | Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care. Receives: Device: VQm Pulmonary Health Monitor™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 12 months
Secondary outcomes (10)
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
Measured: Through study completion, an average of 12 months
Functional residual capacity - trend
Confirming the performance of non-invasive pulmonary health parameter FRC trend found on the VQm PHM™ monitor when compared to available reference measurements
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through completion of study, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilators, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rostrum Medical Innovations Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Initiatives
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147674
- Sponsor's protocol ID
- LM02-CLR-0002
- Status last verified
- Nov 2023
- First submitted
- 26 Jul 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
- ClinicalTrials.gov ID
- NCT06147674
- Acronym / sponsor ID
- LM02-CLR-0002
- Conditions
- Ventilators, Mechanical, Stroke, COPD, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Pneumonia
- Keywords
- Ventilation, ICU, Cardiopulmonary health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rostrum Medical Innovations Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical Initiatives
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VQm PHM™ | – | Device: VQm Pulmonary Health Monitor™Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients currently admitted to the ICUs requiring mechanical ventilation will be screened for potential enrollment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | VQm PHM™ |
Primary outcome
Shunt fraction value
Time frame: 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
10 secondary outcomes
Pulmonary blood flow - trend
Time frame: Through study completion, an average of 12 months
Functional residual capacity - trend
Time frame: Through study completion, an average of 12 months
Pulmonary blood flow - absolute value
Time frame: Through study completion, an average of 12 months
Functional residual capacity - absolute value
Time frame: Through study completion, an average of 12 months
Physiological dead space
Time frame: Through study completion, an average of 12 months
Oxygen desaturation due to breathing circuit connectivity (safety)
Time frame: Through completion of study, up to 72 horus
High pressure due to volume control (safety)
Time frame: Through completion of study, up to 72 hours
High volume due to pressure control (safety)
Time frame: Through completion of study, up to 72 hours
Safe range of nitrous oxide delivery (safety)
Time frame: Through completion of study, up to 72 hours
Incident rate of adverse events, adverse events and treatment-emergent serious adverse events
Time frame: Through completion of study, up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Alexander, MBBS contact
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilators, Mechanical and Stroke, run by Rostrum Medical Innovations Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Austria, Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan Ayoubi (604-439-3054, nathan@rostrummedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shunt fraction value (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.