Clinical trial NCT06147674: Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
Official title: Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventilators, Mechanical
Stroke
COPD
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Pneumonia
Keywords: Ventilation
ICU
Cardiopulmonary health
Lead sponsor: Rostrum Medical Innovations Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical Initiatives
First posted: 2023-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently admitted to the ICUs requiring mechanical ventilation will be screened for potential enrollment.

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.

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

Primary outcomes:
measure: Shunt fraction value
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Pulmonary blood flow - trend
timeFrame: Through study completion, an average of 12 months
measure: Functional residual capacity - trend
timeFrame: Through study completion, an average of 12 months
measure: Pulmonary blood flow - absolute value
timeFrame: Through study completion, an average of 12 months
measure: Functional residual capacity - absolute value
timeFrame: Through study completion, an average of 12 months
measure: Physiological dead space
timeFrame: Through study completion, an average of 12 months
measure: Oxygen desaturation due to breathing circuit connectivity (safety)
timeFrame: Through completion of study, up to 72 horus
measure: High pressure due to volume control (safety)
timeFrame: Through completion of study, up to 72 hours
measure: High volume due to pressure control (safety)
timeFrame: Through completion of study, up to 72 hours
measure: Safe range of nitrous oxide delivery (safety)
timeFrame: Through completion of study, up to 72 hours
measure: Incident rate of adverse events, adverse events and treatment-emergent serious adverse events
timeFrame: Through completion of study, up to 72 hours
Other outcomes:
measure: Shunt fraction changes due to ETT Clamping
timeFrame: Through completion of study, up to 72 hours
measure: PBF changes due to ETT Clamping
timeFrame: Through completion of study, up to 72 hours
measure: FRC changes due to ETT Clamping
timeFrame: Through completion of study, up to 72 hours
measure: VD changes due to ETT Clamping
timeFrame: Through completion of study, up to 72 hours
measure: Shunt fraction changes due to participant positional changes
timeFrame: Through completion of study, up to 72 hours
measure: PBF changes due to participant positional changes
timeFrame: Through completion of study, up to 72 hours
measure: FRC changes due to participant positional changes
timeFrame: Through completion of study, up to 72 hours
measure: VD changes due to participant positional changes
timeFrame: Through completion of study, up to 72 hours
measure: Shunt fraction changes due to delivery of vasopressors
timeFrame: Through completion of study, up to 72 hours
measure: PBF changes due to delivery of vasopressors
timeFrame: Through completion of study, up to 72 hours
measure: FRC changes due to delivery of vasopressors
timeFrame: Through completion of study, up to 72 hours
measure: VD changes due to delivery of vasopressors
timeFrame: Through completion of study, up to 72 hours
measure: Shunt fraction changes due to progression of ARDS
timeFrame: Through completion of study, up to 72 hours
measure: PBF changes due to progression of ARDS
timeFrame: Through completion of study, up to 72 hours
measure: FRC changes due to progression of ARDS
timeFrame: Through completion of study, up to 72 hours
measure: VD changes due to progression of ARDS
timeFrame: Through completion of study, up to 72 hours
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
References: