Healthy VolunteersBRPMSNCT02075346
Bedside Respiratory Patient Monitoring System - Sensor Off Study
An observational study of Healthy Volunteers, run by Medtronic - MITG at 1 site in United States.
Trial summary
Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 20 subjects recruited from the Clinical Laboratory subject data base.
Who may be able to join
- Male or female subjects 18 years or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Who cannot join
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors.
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor.
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Clinical Laboratory
Boulder, Colorado, 80301
About this study
Official title: Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA
Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.
Read the detailed description
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.
The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
- Conditions
- Healthy Volunteers
- Keywords
- Patient safety monitors
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time.
Measured: The planned duration of the study is 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Case only
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Kelley, MD, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075346
- Sponsor's protocol ID
- COVMOPR0419
- Acronym
- BRPMS
- Status last verified
- Dec 2013
- First submitted
- 27 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA
- ClinicalTrials.gov ID
- NCT02075346
- Acronym / sponsor ID
- BRPMS / COVMOPR0419
- Conditions
- Healthy Volunteers
- Keywords
- Patient safety monitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Mar 2014 (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.
Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.
Detailed description
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.
The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 20 subjects recruited from the Clinical Laboratory subject data base.
Key inclusion criteria (3 listed)
- Male or female subjects 18 years or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Key exclusion criteria (3 listed)
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors.
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor.
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
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
To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time.
Time frame: The planned duration of the study is 1 month.
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 3 Mar 2014.
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Screening Protocol
Pain
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 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 Healthy Volunteers, 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 3 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 3 Mar 2014. 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?
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?
To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time. (time frame: The planned duration of the study is 1 month.). 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 3 Mar 2014.