Stroke Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | March 31, 2025 |
Est. primary completion date | January 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna | |
Czechia | University Hospital Kralovske Vinohrady | Prague | |
France | Hôpital Européen Georges Pompidou | Paris | |
United States | UC Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Rostrum Medical Innovations Inc. | Medical Initiatives |
United States, Austria, Czechia, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | PBF changes due to ETT Clamping | Determining the effects of clamping the ETT on PBF compared to baseline | Through completion of study, up to 72 hours | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | Through study completion, an average of 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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