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

• Conditions: Elective Procedures Requiring Mechanical Ventilation

• Registration Number: NCT04730063
• Lead Sponsor: Rostrum Medical Innovations Inc.

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.

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-29
• Study Start: 2021-02-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-01
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States