Non-Invasive Respiratory Volume MonitoringRMI UVUNCT02690298
Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration
An observational study of Non-Invasive Respiratory Volume Monitoring, run by Respiratory Motion, Inc..
Trial summary
Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Invasive Respiratory Volume Monitoring
- What is being tested?
- ExSpiron
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Apr 2016
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Respiratory measurements will be acquired from up to 100 subjects from a wide cross-section of the adult population. Potential subjects will be screened based on the following inclusion/exclusion criteria to determine eligibility.
Who may be able to join
- Males and Females aged 21-90
- Able to provide written informed consent
- Able to participate in a two day study
Who cannot join
- Men and Women aged <21 years and >90 years of age
- Inability to follow study and/or study staff instructions
- Inability to perform study procedures, e.g. spirometry
- Allergy to the electrodes or components of the electrodes
About this study
Official title: Evaluation of ExSpiron™ Non-Invasive Respiratory Volume Monitor Measurements Derived Without Patient Specific Calibration
Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR values measured by the ExSpiron™ without prior spirometer calibration to values obtained with a spirometer calibration. In this study, the MV and TV values will be compared between the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a spirometer
Read the detailed description
In order to evaluate the performance of the device under the range of conditions encountered in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths per minute (the extremes of the rates anticipated to be encountered in the clinical setting), and during erratic breathing, RVM and spirometry measurements were found to be highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93 ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to the spirometer.
The primary objective of the study is to compare the minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron with prior individual specific calibration to a spirometer using either a Wright Spirometer or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be to confirm the PadSet functionality after 24 hours of wear in accordance with current labeling.
- Being tested
- ExSpiron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExSpironDevice
Also called RVM
Non-Invasive respiratory volume monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study is the minute ventilation (MV), in liters per minute (L/min), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
Measured: 3 months
The primary outcome measure of the study is the tidal volume (TV), in liters (L), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
Measured: 3 months
The primary outcome measure of the study is the respiratory rate (RR), in breaths per minute (bpm), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start1 Sep 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive Respiratory Volume MonitoringStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respiratory Motion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690298
- Sponsor's protocol ID
- RMI UVU 2015-0052
- Acronym
- RMI UVU
- Status last verified
- Aug 2018
- First submitted
- 8 Sep 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ExSpiron™ Non-Invasive Respiratory Volume Monitor Measurements Derived Without Patient Specific Calibration
- ClinicalTrials.gov ID
- NCT02690298
- Acronym / sponsor ID
- RMI UVU / RMI UVU 2015-0052
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Respiratory Motion, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR values measured by the ExSpiron™ without prior spirometer calibration to values obtained with a spirometer calibration. In this study, the MV and TV values will be compared between the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a spirometer
Detailed description
In order to evaluate the performance of the device under the range of conditions encountered in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths per minute (the extremes of the rates anticipated to be encountered in the clinical setting), and during erratic breathing, RVM and spirometry measurements were found to be highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93 ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to the spirometer.
The primary objective of the study is to compare the minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron with prior individual specific calibration to a spirometer using either a Wright Spirometer or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be to confirm the PadSet functionality after 24 hours of wear in accordance with current labeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Respiratory measurements will be acquired from up to 100 subjects from a wide cross-section of the adult population. Potential subjects will be screened based on the following inclusion/exclusion criteria to determine eligibility.
Key inclusion criteria (3 listed)
- Males and Females aged 21-90
- Able to provide written informed consent
- Able to participate in a two day study
Key exclusion criteria (4 listed)
- Men and Women aged <21 years and >90 years of age
- Inability to follow study and/or study staff instructions
- Inability to perform study procedures, e.g. spirometry
- Allergy to the electrodes or components of the electrodes
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 |
|---|---|---|
| ExSpironAlso: RVMNon-Invasive respiratory volume monitoring | Device | – |
Primary outcome
The primary outcome measure of the study is the minute ventilation (MV), in liters per minute (L/min), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Time frame: 3 months
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
The primary outcome measure of the study is the tidal volume (TV), in liters (L), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Time frame: 3 months
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
The primary outcome measure of the study is the respiratory rate (RR), in breaths per minute (bpm), collected and reported by the ExSpiron, with and without prior ExSpiron calibration
Time frame: 3 months
Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Invasive Respiratory Volume Monitoring, run by Respiratory Motion, Inc..
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure of the study is the minute ventilation (MV), in liters per minute (L/min), collected and reported by the ExSpiron, with and without prior ExSpiron calibration (time frame: 3 months). The study lists 3 primary outcomes in all. 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 28 Aug 2018.