Recruiting

Cardio-Pulmonary Monitor

Sponsor:

Rostrum Medical Innovations Inc.

Code:

NCT04730063

Conditions

Elective Procedures Requiring Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

VQm PHM™

Study Details

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.

Conditions

Elective Procedures Requiring Mechanical Ventilation

Study ID

NCT04730063

Start date

Feb 17, 2021

Status verified date

Apr, 2022

Completion date

Feb, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

VQm PHM™

Procedure: Non-invasive measurements obtained with the VQm PHM™

Primary outcome measure

  • Comparison of pulmonary function parameters to known clinical standards [ Time Frame: Through study completion, an average of 12 months ]

Central Contacts and Locations

Central contacts

Neal W Fleming, M.D., Ph.D.

916-734-5394nwfleming@ucdavis.edu

Nathan Ayoubi, BSc

604 562 6198nathan@rostrummedical.com

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Neal W Fleming, M.D., Ph.D.

916-734-5394nwfleming@ucdavis.edu

Principal Investigator:

Neal W Fleming, M.D., Ph.D.

More Information

Sponsor

Rostrum Medical Innovations Inc.

Last update posted

Apr 27, 2022

Last verified

Apr, 2022

Keywords

  • Physiologic Monitors
  • Acute Care Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rostrum Medical Innovations Inc. on 2022-04-27.