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Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

NCT06147674 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-11-27

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Medical Initiatives

    collaborator NETWORK

  • Rostrum Medical Innovations Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-01-15
Completion
2025-03-31

Countries

  • United States
  • Austria
  • Czechia
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147674 on ClinicalTrials.gov