Elective Procedures Requiring Mechanical VentilationNCT04730063
Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine
An observational study of Elective Procedures Requiring Mechanical Ventilation, run by Rostrum Medical Innovations Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Procedures Requiring Mechanical Ventilation
- What is being tested?
- VQm PHM™
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective surgery requiring mechanical ventilation
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Neal W Fleming, M.D., Ph.D., 916-734-5394, nwfleming@ucdavis.edu
Neal W Fleming, M.D., Ph.D.
About this study
Official title: Prospective Non-Interventional Study Evaluating Non-invasive Measurements of Pulmonary Blood Flow, Functional Residual Capacity, Shunt Fraction Index and Airway Dead Space Measured With the VQm PHM™ to Clinical Gold Standards
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.
Read the 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.
- Being tested
- VQm PHM™
- Keywords
- Physiologic Monitors, Acute Care Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VQm PHM™Device
Procedure: Non-invasive measurements obtained with the VQm PHM™
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pulmonary function parameters to known clinical standards
Assess agreement between measurements from VQm PHM™ to clinical gold standards
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start17 Feb 2021
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Procedures Requiring Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rostrum Medical Innovations Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Neal W Fleming, M.D., Ph.D., Principal investigator, Director, Cardiovascular and Thoracic Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730063
- Sponsor's protocol ID
- 1685958-2
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Study Evaluating Non-invasive Measurements of Pulmonary Blood Flow, Functional Residual Capacity, Shunt Fraction Index and Airway Dead Space Measured With the VQm PHM™ to Clinical Gold Standards
- ClinicalTrials.gov ID
- NCT04730063
- Acronym / sponsor ID
- 1685958-2
- Keywords
- Physiologic Monitors, Acute Care Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rostrum Medical Innovations Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery requiring mechanical ventilation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients who require ventilation tidal volumes less than 250cc
- Age less than 18 years
- Pregnancy
- Prisoners
- Surgical procedure which requires carbon dioxide (CO2) insufflation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VQm PHM™Procedure: Non-invasive measurements obtained with the VQm PHM™ | Device | – |
Primary outcome
Comparison of pulmonary function parameters to known clinical standards
Time frame: Through study completion, an average of 12 months
Assess agreement between measurements from VQm PHM™ to clinical gold standards
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal W Fleming, M.D., Ph.D. principal investigator
Director, Cardiovascular and Thoracic Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Procedures Requiring Mechanical Ventilation, run by Rostrum Medical Innovations Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neal W Fleming, M.D., Ph.D. (916-734-5394, nwfleming@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pulmonary function parameters to known clinical standards (time frame: Through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.