HealthyNCT03897179
INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
A study testing INVSENSOR00032 and INVSENSOR00033 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- INVSENSOR00032 and INVSENSOR00033
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 25 Feb 2019
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical status of ASA I or II
- Must be able to read and communicate in English
- Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
- Passed health assessment screening
- Negative pregnancy test for female subjects of child bearing potential.
Who cannot join
- Physical status of ASA III, IV, or V
- Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- Inability to tolerate sitting still or minimal movement for at least 30 minutes
- Positive pregnancy test for female subjects
- Refusal to take pregnancy test for women of child bearing potential
- Nursing female subjects
Show all 10Show fewer
- Subjects wearing acrylic nails or subjects refusing to remove nail polish
- Subjects who have a nail deformity on the measurement finger
- Subjects who do not have adequate skin integrity on the measurement finger
- Excluded at the Principal Investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- INVSENSOR00032 and INVSENSOR00033
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00032 and INVSENSOR00033Device
Investigational pulse oximeter device
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00032 and INVSENSOR00033 test group | Experimental | All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. Receives: Device: INVSENSOR00032 and INVSENSOR00033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RRp Arms of Sensor Accuracy
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.
Measured: 1-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start13 Feb 2019
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
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 HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897179
- Sponsor's protocol ID
- TP-19608
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2019
- Last updated
- 27 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
- ClinicalTrials.gov ID
- NCT03897179
- Acronym / sponsor ID
- TP-19608
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00032 and INVSENSOR00033 test group | Experimental | Device: INVSENSOR00032 and INVSENSOR00033All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physical status of ASA I or II
- Must be able to read and communicate in English
- Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
- Passed health assessment screening
- Negative pregnancy test for female subjects of child bearing potential.
Key exclusion criteria (10 listed)
- Physical status of ASA III, IV, or V
- Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- Inability to tolerate sitting still or minimal movement for at least 30 minutes
- Positive pregnancy test for female subjects
- Refusal to take pregnancy test for women of child bearing potential
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 |
|---|---|---|
| INVSENSOR00032 and INVSENSOR00033Investigational pulse oximeter device | Device | INVSENSOR00032 and INVSENSOR00033 test group |
Primary outcome
RRp Arms of Sensor Accuracy
Time frame: 1-5 hours
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVSENSOR00032 and INVSENSOR00033 in people with Healthy, run by Masimo Corporation 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 5 inclusion and 10 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 27 Mar 2020. 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 27 Mar 2020). 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?
RRp Arms of Sensor Accuracy (time frame: 1-5 hours). 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 Mar 2020.