Respiratory RateNCT03306537
Sensor Validation Study - Quality Assurance
An observational study of Respiratory Rate, run by PMD Solutions at 1 site in United Kingdom.
Trial summary
The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- RespiraSense Respiratory Rate Monitor
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jul 2017to 7 Sep 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Obese patients with a BMI ≥35
Who may be able to join
- ≥ 18 Years
- Have a BMI ≥35
- For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI > 50 will be needed
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Who cannot join
- Allergic to medical grade skin adhesive
- Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
- Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology
The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so that the measurements can be taken.
A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass.
Subjects with a BMI > 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared
- Conditions
- Respiratory Rate
- Being tested
- RespiraSense Respiratory Rate Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespiraSense Respiratory Rate MonitorDevice
RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PMD RespiraSense against capnography in obese patients.
Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Measured: 1 hour
Secondary outcomes (3)
Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.
Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Measured: 1 hour
Identification of any accuracy spread patterns as BMI increases.
Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Measured: 1 hour
Collection of feedback on device comfort when worn by patients with high BMI.
Will not be analysed formally.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start28 Jul 2017
- Primary completion7 Aug 2018
- Study completion7 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RateStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMD Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorraine Albon, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306537
- Sponsor's protocol ID
- PMD-CS-011
- Status last verified
- Mar 2019
- First submitted
- 29 Sep 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Assurance Study of Respiratory Rate Measurements on Obese Patients With a Novel Monitoring Technology
- ClinicalTrials.gov ID
- NCT03306537
- Acronym / sponsor ID
- PMD-CS-011
- Conditions
- Respiratory Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PMD SolutionsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 11 Oct 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 respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so that the measurements can be taken.
A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass.
Subjects with a BMI > 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Obese patients with a BMI ≥35
Key inclusion criteria (4 listed)
- ≥ 18 Years
- Have a BMI ≥35
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Key exclusion criteria (4 listed)
- Allergic to medical grade skin adhesive
- Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
- Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
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 |
|---|---|---|
| RespiraSense Respiratory Rate MonitorRespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour | Device | – |
Primary outcome
Comparison of PMD RespiraSense against capnography in obese patients.
Time frame: 1 hour
Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
3 secondary outcomes
Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.
Time frame: 1 hour
Identification of any accuracy spread patterns as BMI increases.
Time frame: 1 hour
Collection of feedback on device comfort when worn by patients with high BMI.
Time frame: 1 hour
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 20 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Lorraine Albon principal investigator
Portsmouth Hospitals NHS Trust
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 Rate, run by PMD Solutions at 1 site in United Kingdom.
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 4 inclusion and 4 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 20 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 Kingdom. 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?
Comparison of PMD RespiraSense against capnography in obese patients. (time frame: 1 hour). 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 20 Mar 2019.