Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Status unconfirmed

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

In brief

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.

Key facts

Study ID

NCT06147674

Run by

Rostrum Medical Innovations Inc.

People needed

150

Starts

2024-01-15

Expected to finish

2025-03-31

Last updated by the study team

2023-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Medical University of Vienna — Vienna, Austria
• University Hospital Kralovske Vinohrady — Prague, Czechia
• Hôpital Européen Georges Pompidou — Paris, France

Full record on ClinicalTrials.gov

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