Respiratory InsufficiencyNCT03592914
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients
An observational study of Respiratory Insufficiency, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 16 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who might be seen in a respiratory rehabilitation center.
Who may be able to join
- The subject is at least 18 years old;
- The subject has given written informed consent to participate in the study;
- The subject is both willing and able to comply with study procedures.
Who cannot join
- The subject has a history of or current atrial fibrillation;
- The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds;
- The subject has an implanted pacemaker;
- The subject has had any relevant injury at the sensor location site (self-reported);
- The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
- The subject is currently or trying to get pregnant (self-reported); and/or
- The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Read the detailed description
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Objective(s):
The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR < 1.0 BPM during spontaneous breathing.
- Conditions
- Respiratory Insufficiency
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| subjects with respiratory disease | This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3
Measure respiratory rates
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start31 Jul 2018
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Valley Inspired Products
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592914
- Sponsor's protocol ID
- QATP3161
- Status last verified
- Mar 2019
- First submitted
- 9 Jul 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03592914
- Acronym / sponsor ID
- QATP3161
- Conditions
- Respiratory Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Valley Inspired Products
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 19 Jul 2018 (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.
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Detailed description
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Objective(s):
The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR < 1.0 BPM during spontaneous breathing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with respiratory disease | – | –This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who might be seen in a respiratory rehabilitation center.
Key inclusion criteria (3 listed)
- The subject is at least 18 years old;
- The subject has given written informed consent to participate in the study;
- The subject is both willing and able to comply with study procedures.
Key exclusion criteria (7 listed)
- The subject has a history of or current atrial fibrillation;
- The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds;
- The subject has an implanted pacemaker;
- The subject has had any relevant injury at the sensor location site (self-reported);
- The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
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
Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3
Time frame: 40 minutes
Measure respiratory rates
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 12 Mar 2019.
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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?
An observational study of Respiratory Insufficiency, run by Nonin Medical, 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 3 inclusion and 7 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 12 Mar 2019. 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?
Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 (time frame: 40 minutes). 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 12 Mar 2019.