Evaluation of Novel Cardio-Pulmonary Physiological Monito... | NCT04730063

Studies
Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine

NCT04730063

Sponsor

Rostrum Medical Innovations Inc.

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Elective Procedures Requiring Mechanical Ventilation

Interventions

VQm PHM™

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2021Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Jan 25, 2021

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2022

Last Update Posted Date

Apr 27, 2022Actual

Name	Class
University of California, Davis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, observational study to assess agreement of pulmonary health parameters measured by a new non-invasive physiologic monitor, the VQm pulmonary health monitor (PHM)™ with clinical gold standards.

Detailed Description

The specific aim of this study is to evaluate the intermittent non-invasive measurements of pulmonary function: pulmonary blood flow (PBF), functional residual capacity (FRC), shunt fraction index (Qsi) and airway dead space measured by the VQm PHM™ compared to known clinical standards. PBF will be compared to continuous and intermittent bolus thermodilution cardiac output as measured through a Swan-Ganz catheter. FRC will be compared to an FRC measurement provided by a standard nitrogen washout method. Qsi will be compared to shunt fraction calculated through mixed venous and arterial blood gas values (VBGs/ABGs). Airway dead space will be compared to an airway dead space measurement provided by a ventilator.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
VQm PHM™	Device	Procedure: Non-invasive measurements obtained with the VQm PHM™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of pulmonary function parameters to known clinical standards	Assess agreement between measurements from VQm PHM™ to clinical gold standards	Through study completion, an average of 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 18 years
Scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia without the use of inhalation anesthetics
Surgical procedure that requires pressure-controlled positive pressure ventilation using an endotracheal tube
Surgical procedure that requires the use of intra-arterial pressure monitoring and/or a Swan-Ganz catheter for the monitoring of continuous cardiac output

Exclusion Criteria:

Patients who require ventilation tidal volumes less than 250cc
Age less than 18 years
Pregnancy
Prisoners
Surgical procedure which requires carbon dioxide (CO2) insufflation
Unable to tolerate a transient increase in inhaled CO2
Unable to tolerate a transient increase in inhaled nitrous oxide (N2O) or use of N2O is contraindicated
Patients who require a high fraction of inspired oxygen (FiO2) (>70%) to maintain a hemoglobin saturation (SpO2>98%)

Women, minorities or non-English speaking subjects will not be excluded

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective surgery requiring mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neal W Fleming, M.D., Ph.D.	Contact	916-734-5394		nwfleming@ucdavis.edu
Nathan Ayoubi, BSc	Contact	604 562 6198		nathan@rostrummedical.com

Overall Officials

Name	Affiliation	Role
Neal W Fleming, M.D., Ph.D.	Director, Cardiovascular and Thoracic Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center	Recruiting	Sacramento	California	95817	United States