Normal Respiration PatternsNCT03223870
Respiratory Rate Accuracy - Healthy Adults
An observational study of Normal Respiration Patterns, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Respiration Patterns
- What is being tested?
- Diagnostic
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 31 Jul 2017
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A minimum of 30 subjects will be included in this study. The subject selection will be an approximately equal mix of males and females with varying skin tones. At a rate of 3-4 subjects per day, enrollment will take approximately 7-10 days to complete.
Who may be able to join
- The subject is male or female
- The subject is of any racial or ethnic group
- The subject is > 30 kg (>66 pounds) in weight (based on measurement)
- The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
- The subject is between 18 years and 50 years of age (self-reported)
- 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 BMI greater than 30 (based on weight and height)
- The subject has a history of atrial fibrillation (self-reported)
- The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
- The subject has an implanted pacemaker (self-reported)
- 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)
Show all 12Show fewer
- The subject has a known respiratory condition (self-reported)
- The subject has a known heart or cardiovascular condition (self-reported)
- The subject is currently pregnant (self-reported)
- The subject is actively trying to get pregnant (self-reported)
- The subject is unwilling or unable to provide written informed consent to participate in the study
- The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.
Read the detailed description
- Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
- Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
- Collect Demographic and Anthropometric Data from the subject.
- Place Pulse Oximetry Sensors
- Place nasal cannula for capnography recordings
- A summary of Respiratory rate protocol.
- Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system.
- Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.
- Conditions
- Normal Respiration Patterns
- Being tested
- Diagnostic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticDiagnostic test
Diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Oximeters | Comparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed. Receives: Diagnostic Test: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate Accuracy
Values from the test device will be compared to the values from co-oximetry devices
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 posted21 Jul 2017
- Study start11 Jul 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Respiration PatternsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Holbein, Ph.D, Principal investigator, Nonin Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223870
- Sponsor's protocol ID
- QATP3064
- Status last verified
- Aug 2017
- First submitted
- 13 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Accuracy - Healthy Adults
- ClinicalTrials.gov ID
- NCT03223870
- Acronym / sponsor ID
- QATP3064
- Conditions
- Normal Respiration Patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 21 Jul 2017 (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.
The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.
Detailed description
- Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
- Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
- Collect Demographic and Anthropometric Data from the subject.
- Place Pulse Oximetry Sensors
- Place nasal cannula for capnography recordings
- A summary of Respiratory rate protocol.
- Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system.
- Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oximeters | – | Diagnostic Test: DiagnosticComparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A minimum of 30 subjects will be included in this study. The subject selection will be an approximately equal mix of males and females with varying skin tones. At a rate of 3-4 subjects per day, enrollment will take approximately 7-10 days to complete.
Key inclusion criteria (7 listed)
- The subject is male or female
- The subject is of any racial or ethnic group
- The subject is > 30 kg (>66 pounds) in weight (based on measurement)
- The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
- The subject is between 18 years and 50 years of age (self-reported)
Key exclusion criteria (12 listed)
- The subject has a BMI greater than 30 (based on weight and height)
- The subject has a history of atrial fibrillation (self-reported)
- The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
- The subject has an implanted pacemaker (self-reported)
- The subject has had any relevant injury at the sensor location site (self-reported)
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 |
|---|---|---|
| DiagnosticDiagnostic | Diagnostic test | Oximeters |
Primary outcome
Respiratory Rate Accuracy
Time frame: 3 months
Values from the test device will be compared to the values from co-oximetry devices
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 2 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Normal Respiration Patterns
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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.
Walter Holbein, Ph.D principal investigator
Nonin Medical, Inc
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 Normal Respiration Patterns, 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 7 inclusion and 12 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 2 Aug 2017. 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?
Respiratory Rate Accuracy (time frame: 3 months). 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 2 Aug 2017.