Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Pneumonia; COPD; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Ventilators, Mechanical
• Intervention / Treatment: Device: VQm Pulmonary Health Monitor™

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Nathan Ayoubi; Phone Number: 604-439-3054; Email: nathan@rostrummedical.com
• Study Contact Backup: Name: Scott Alexander, MBBS; Email: scott.alexander@rostrummedical.com

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna
    • Contact: Maximilian Edlinger-Stanger, M.D.; Phone Number: +43 1 4016056515; Email: maximilian.edlingerstanger@meduniwien.ac.at
• Czechia
  • Prague, Czechia, 10034
    • University Hospital Královské Vinohrady
    • Contact: Frantisek Duska, M.D.; Phone Number: +421 2/671 637 78; Email: Frantisek.duska@lf3.cuni.cz
• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
    • Contact: Bernard P Cholley, M.D., Ph.D.; Phone Number: +33 1 56 09 20 00; Email: bernard.cholley@aphp.fr
• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
      • Contact: Neal W Flemming, M.D., Ph.D.; Phone Number: 916-734-5394; Email: nwfleming@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients currently admitted to the ICUs requiring mechanical ventilation will be screened for potential enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rostrum Medical Innovations Inc.
• Collaborators: Medical Initiatives

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ICU; Ventilation; Cardiopulmonary health
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: LM02-CLR-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No