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ClinicalTrials.gov ID

NCT06147674

Lead Sponsor

Rostrum Medical Innovations Inc.INDUSTRY

Overall Status

Unknown status

Study Type

Observational

Enrollment

150Estimated

Last Update Posted

Nov 27, 2023Actual

Start Date

Jan 15, 2024Estimated

Primary Completion Date

Jan 15, 2025Estimated

Completion Date

Mar 31, 2025Estimated

Official Title

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

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.

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.

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

• VQm Pulmonary Health Monitor™

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Rostrum Medical Innovations Inc.INDUSTRY

Collaborators

Medical InitiativesNETWORK

maximilian.edlingerstanger@meduniwien.ac.at+43 1 4016056515

bernard.cholley@aphp.fr+33 1 56 09 20 00