This study is not yet accepting patients

Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

a study on Ventilators, Mechanical Stroke Chronic Obstructive Pulmonary Disease Acute Lung Injury Acute Respiratory Distress Syndrome Respiratory Distress Syndrome Pneumonia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Ventilators, Mechanical, Stroke, COPD, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Pneumonia, Ventilation, ICU, Cardiopulmonary health, Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Acute Lung Injury, Lung Injury, VQm Pulmonary Health Monitor™, VQm PHM™

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Hôpital Européen Georges Pompidou
    Paris 75015 France
  • University Hospital Kralovske Vinohrady
    Prague 10034 Czechia
  • Medical University of Vienna
    Vienna 1090 Austria

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Rostrum Medical Innovations Inc.
ID
NCT06147674
Study Type
Observational
Participants
Expecting 150 study participants
Last Updated