Respiratory RateNCT03148873
RespiraSense Versus Capnography & Manual Counting
An observational study of Respiratory Rate, run by PMD Solutions at 1 site in United Kingdom.
Trial summary
Your respiratory rate is your number of breaths per minute. The standard way for this to be measured is by a nurse looking at you for one minute and manually counting your breaths over this time. They normally do this once every few hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- RespiraSense patient respiratory monitor system
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2017to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population to be studied are patients that have been admitted to the Acute Medical Unit and to be measured within the first 24 hours of this admission episode either on this unit or on whichever ward they have been transferred to.
Who may be able to join
- ≥18 years
- Acute admission to be measured within the first 24 hours of this admission episode
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Who cannot join
- Allergic to medical grade skin adhesive
- Pregnant women during second and third trimester
- Patients who are determined by the medical team to have fragile skin unsuitable for application of the adhesive of the RespiraSense sensor. 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 freely give full informed consent
- Patients whose health is deteriorating and unstable
- Patients with predominant palliative care needs
- Patients with a National Early Warning Score (NEWS) of > 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Continuous Monitoring Device in Capturing Respiratory Rate Compared to Industry Standard & Gold Standard
Your respiratory rate is your number of breaths per minute. The standard way for this to be measured is by a nurse looking at you for one minute and manually counting your breaths over this time. They normally do this once every few hours. At times, it can be useful to have your respiratory rate continuously monitored. A device that can do this is a 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 the measurements can be taken.
This research study is looking at a new respiratory rate monitor and comparing how well it works against the current accepted methods.
Read more
Patients who are admitted to the Acute Medical Unit will be invited to participate should they meet all eligibility criteria.
Subjects will be monitored for two hours:
(i) For the first hour subjects will wear a capnograph, RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject will be asked to keep talking and moving to a minimum.
(ii) For the second hour subjects will wear RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject can talk and move as they wish.
- Conditions
- Respiratory Rate
- Being tested
- RespiraSense patient respiratory monitor system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespiraSense patient respiratory monitor systemDevice
Also called Capnograph as comparator - Nonin LifeSense Model LS1-9R
Subjects will have their respiratory rate monitored for two hours using three different methods for capturing it
What is being measured
The primary outcome is the main question the study is designed to answer.
RespiraSense versus capnography
Average respiratory rate
Measured: 15 minute windows for the first hour of monitoring
Secondary outcomes (1)
RespiraSense versus manual counting
Average respiratory rate
Measured: 15 minute windows for the full two hours of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start8 May 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMD Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Subbe, Principal investigator, BCUHB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148873
- Sponsor's protocol ID
- PMD-CS-007
- Status last verified
- Aug 2018
- First submitted
- 9 May 2017
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Continuous Monitoring Device in Capturing Respiratory Rate Compared to Industry Standard & Gold Standard
- ClinicalTrials.gov ID
- NCT03148873
- Acronym / sponsor ID
- PMD-CS-007
- Conditions
- Respiratory Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PMD SolutionsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 May 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.
Your respiratory rate is your number of breaths per minute. The standard way for this to be measured is by a nurse looking at you for one minute and manually counting your breaths over this time. They normally do this once every few hours. At times, it can be useful to have your respiratory rate continuously monitored. A device that can do this is a 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 the measurements can be taken.
This research study is looking at a new respiratory rate monitor and comparing how well it works against the current accepted methods.
Patients who are admitted to the Acute Medical Unit will be invited to participate should they meet all eligibility criteria.
Subjects will be monitored for two hours:
(i) For the first hour subjects will wear a capnograph, RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject will be asked to keep talking and moving to a minimum.
(ii) For the second hour subjects will wear RespiraSense and have their respiratory rate manually counted by a research nurse. During this time the subject can talk and move as they wish.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied are patients that have been admitted to the Acute Medical Unit and to be measured within the first 24 hours of this admission episode either on this unit or on whichever ward they have been transferred to.
Key inclusion criteria (3 listed)
- ≥18 years
- Acute admission to be measured within the first 24 hours of this admission episode
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Key exclusion criteria (7 listed)
- Allergic to medical grade skin adhesive
- Pregnant women during second and third trimester
- Patients who are determined by the medical team to have fragile skin unsuitable for application of the adhesive of the RespiraSense sensor. 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 freely give full informed consent
- Patients whose health is deteriorating and unstable
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 patient respiratory monitor systemAlso: Capnograph as comparator - Nonin LifeSense Model LS1-9RSubjects will have their respiratory rate monitored for two hours using three different methods for capturing it | Device | – |
Primary outcome
RespiraSense versus capnography
Time frame: 15 minute windows for the first hour of monitoring
Average respiratory rate
1 secondary outcome
RespiraSense versus manual counting
Time frame: 15 minute windows for the full two hours of monitoring
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 29 Aug 2018.
- 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.
Christian Subbe principal investigator
BCUHB
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 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 29 Aug 2018. 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?
RespiraSense versus capnography (time frame: 15 minute windows for the first hour of monitoring). 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 29 Aug 2018.