Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Stroke Clinical Trial

Official title:

Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147674
• Other study ID #: LM02-CLR-0002
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Rostrum Medical Innovations Inc.
• Contact: Nathan Ayoubi
• Phone: 604-439-3054
• Email: nathan[@]rostrummedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
• COPD
• Lung Injury
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Stroke
• Ventilators, Mechanical

Intervention

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)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rostrum Medical Innovations Inc.	Medical Initiatives

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  France, 

Outcome

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