Focus of the Study is Measuring Respiratory RateNCT01804062
Respiration Rate V2.0 in Healthy Volunteers
An observational study of Focus of the Study is Measuring Respiratory Rate, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Measuring Respiratory Rate
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer subjects with no significant medical problems
Who may be able to join
- Male or female subjects.
- 18 years or older.
- Subject is willing and able to provide written consent.
Who cannot join
- Subject is younger than 18.
- Subject is pregnant or lactating
- Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- Subject has an abnormality that may prevent proper application of the device.
- Subject is in atrial fibrillation.
- Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
- Subject has an implanted pacemaker.
- Subject is unwilling or unable to sign informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder In-House Clinical Laboratory
Boulder, Colorado, 80301
About this study
Official title: Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).
Read the detailed description
Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.
The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | no treatment, prospective observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Measured: up to 40 minutes of continous monitoring
Secondary outcomes (1)
ME +/- 1 Breath Per Minute, Max-N Sensor
The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Measured: up to 40 minutes of continuous monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Focus of the Study is Measuring Respiratory RateStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott D Kelley, MD, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804062
- Sponsor's protocol ID
- COVMOPR0394
- Status last verified
- Jul 2015
- First submitted
- 20 Feb 2013
- Last updated
- 10 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
- ClinicalTrials.gov ID
- NCT01804062
- Acronym / sponsor ID
- COVMOPR0394
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).
Detailed description
Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.
The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | –no treatment, prospective observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer subjects with no significant medical problems
Key inclusion criteria (3 listed)
- Male or female subjects.
- 18 years or older.
- Subject is willing and able to provide written consent.
Key exclusion criteria (8 listed)
- Subject is younger than 18.
- Subject is pregnant or lactating
- Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- Subject has an abnormality that may prevent proper application of the device.
- Subject is in atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Time frame: up to 40 minutes of continous monitoring
The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
1 secondary outcome
ME +/- 1 Breath Per Minute, Max-N Sensor
Time frame: up to 40 minutes of continuous monitoring
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Scott D Kelley, MD principal investigator
Medtronic - MITG
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 Focus of the Study is Measuring Respiratory Rate, run by Medtronic - MITG 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 3 inclusion and 8 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 10 Aug 2015. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor (time frame: up to 40 minutes of continous monitoring). 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 10 Aug 2015.