Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

NCT06147674 | Unknown

• 1 other identifier: LM02-CLR-0002
• Study Type: observational
• Target: 150
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

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

Keywords

Ventilation; ICU; Cardiopulmonary health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pulmonary blood flow - trend

  Through study completion, an average of 12 months

• Functional residual capacity - trend

  Through study completion, an average of 12 months

• Pulmonary blood flow - absolute value

  Through study completion, an average of 12 months

• Functional residual capacity - absolute value

  Through study completion, an average of 12 months

• Physiological dead space

  Through study completion, an average of 12 months

Other Outcomes (16)

• Shunt fraction changes due to ETT Clamping

  Through completion of study, up to 72 hours

• PBF changes due to ETT Clamping

  Through completion of study, up to 72 hours

• FRC changes due to ETT Clamping

  Through completion of study, up to 72 hours

Study Arms (1)

VQm PHM™

Non-invasive measurements obtained with the VQm PHM™ compared to current standard of care.

Device: VQm Pulmonary Health Monitor™

Interventions

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)

VQm PHM™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rostrum Medical Innovations Inc.: lead
• Medical Initiatives: collaborator

Study Sites (4)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Stroke; Pulmonary Disease, Chronic Obstructive; Acute Lung Injury; Respiratory Distress Syndrome; Pneumonia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Respiration Disorders; Respiratory Tract Infections; Infections

Central Study Contacts

Nathan Ayoubi

CONTACT

604-439-3054; nathan@rostrummedical.com

Scott Alexander, MBBS

CONTACT

scott.alexander@rostrummedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: November 27, 2023
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 31, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1); CZ (1); AU (1)