Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06147674 | NOT YET RECRUITING | Ventilators, Mechanical

Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
Sponsor:

Rostrum Medical Innovations Inc.

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.

Condition or disease

Ventilators, Mechanical

Stroke

COPD

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Pneumonia

Intervention/treatment

VQm Pulmonary Health Monitor™

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
Actual Study Start Date : 2024-01-15
Estimated Primary Completion Date : 2025-01-15
Estimated Study Completion Date : 2025-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Location Details

NCT06147674

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

UC Davis Medical Center

Sacramento, California, United States, 95817

Not yet recruiting

Austria,

Medical University of Vienna

Vienna, Austria, 1090

Not yet recruiting

Czechia,

University Hospital Kralovske Vinohrady

Prague, Czechia, 10034

Not yet recruiting

France,

Georges Pompidou European Hospital

Paris, France, 75015