Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
NCT ID: NCT06147674
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2024-01-15
2025-03-31
Brief Summary
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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.
* 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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VQm PHM™
Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical Initiatives
NETWORK
Rostrum Medical Innovations Inc.
INDUSTRY
Responsible Party
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Locations
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UC Davis Medical Center
Sacramento, California, United States
Medical University of Vienna
Vienna, , Austria
University Hospital Kralovske Vinohrady
Prague, , Czechia
Hôpital Européen Georges Pompidou
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LM02-CLR-0002
Identifier Type: -
Identifier Source: org_study_id