ChildrenBreatheasyNCT04215887
Noncontact, Handheld Device for Measurement of Respiratory Rate
An observational study of Children, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In the emergency department, a sick child is usually seen first by a nurse. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use electronic devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- Contactless Portable Respiratory rate Monitor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2015to 1 Nov 2015
- 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 0 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults or children requiring a respiratory rate measurement
Who may be able to join
- any person requiring and able to perform a respiratory rate measurement
Who cannot join
- people assessed as too unwell to participate by clinical team
- people for whom English is not first language as no interpreting service included in budget
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Development of the "BreathEasy": a Non-contact, Hand-held Device for Measurement of Respiratory Rate (CPRM)
In the emergency department, a sick child is usually seen first by a nurse. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use electronic devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, the nurse normally has to manually count the respiration rate (this is the number of breaths taken each minute) because there is no suitable device which can do this automatically. Knowing the respiration rate is very important because if it is not normal, the nurse knows that the child may be seriously ill. Counting the respiration rate of sick children can be difficult and takes up a lot of time, especially if the child is upset, crying or moving about. To overcome this problem we are developing a device that automatically measures respiration rate in children. It works by directly sensing the air coming from the nose or the mouth when held at a small distance (about 30 cm) from the face. So far, the device has been shown to work in a research laboratory at Sheffield Hallam University. The aim is to develop it into a handheld, userfriendly device, ensuring that it complies with strict safety regulations. This application is to carry out an evaluation of our new device against its gold standard, on adult volunteers and on children attending Sheffield Children's Hospital for sleep studies as part of their clinical care. In the future, when nurses use the device they will easily be able to measure each child's respiration rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly. This will ensure that the right children get admitted to intensive care units sooner and, in some cases, child deaths will be prevented.
- Conditions
- Children
- Being tested
- Contactless Portable Respiratory rate Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contactless Portable Respiratory rate MonitorDevice
Also called "Breatheasy"
Novel hand-held respiratory rate monitor
| Study group | Role | What they receive |
|---|---|---|
| Sleep unit | Children admitted to sleep unit for sleep study Receives: Device: Contactless Portable Respiratory rate Monitor | |
| School | Healthy children in school Receives: Device: Contactless Portable Respiratory rate Monitor | |
| Emergency department | Children seen in triage in emergency department at SCH Receives: Device: Contactless Portable Respiratory rate Monitor | |
| General practice | Adults or children attending general practice Receives: Device: Contactless Portable Respiratory rate Monitor | |
| Ambulance | Adults or children in rapid response vehicle Receives: Device: Contactless Portable Respiratory rate Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the experimental technique and the gold standard (contact based thermistor system).
Correlation between device respiratory rate measurement of and measurement using respiratory impedance plethysmography will be examined.
Measured: Through study completion (less than 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start16 Feb 2015
- Primary completionNov 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Heather Elphick, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215887
- Sponsor's protocol ID
- SCH/13/018
- Acronym
- Breatheasy
- Status last verified
- Dec 2019
- First submitted
- 1 Apr 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the "BreathEasy": a Non-contact, Hand-held Device for Measurement of Respiratory Rate (CPRM)
- ClinicalTrials.gov ID
- NCT04215887
- Acronym / sponsor ID
- Breatheasy / SCH/13/018
- Conditions
- Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University, University of Sheffield
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 2 Jan 2020 (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.
In the emergency department, a sick child is usually seen first by a nurse. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use electronic devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, the nurse normally has to manually count the respiration rate (this is the number of breaths taken each minute) because there is no suitable device which can do this automatically. Knowing the respiration rate is very important because if it is not normal, the nurse knows that the child may be seriously ill. Counting the respiration rate of sick children can be difficult and takes up a lot of time, especially if the child is upset, crying or moving about. To overcome this problem we are developing a device that automatically measures respiration rate in children. It works by directly sensing the air coming from the nose or the mouth when held at a small distance (about 30 cm) from the face. So far, the device has been shown to work in a research laboratory at Sheffield Hallam University. The aim is to develop it into a handheld, userfriendly device, ensuring that it complies with strict safety regulations. This application is to carry out an evaluation of our new device against its gold standard, on adult volunteers and on children attending Sheffield Children's Hospital for sleep studies as part of their clinical care. In the future, when nurses use the device they will easily be able to measure each child's respiration rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly. This will ensure that the right children get admitted to intensive care units sooner and, in some cases, child deaths will be prevented.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sleep unit | – | Device: Contactless Portable Respiratory rate MonitorChildren admitted to sleep unit for sleep study |
| School | – | Device: Contactless Portable Respiratory rate MonitorHealthy children in school |
| Emergency department | – | Device: Contactless Portable Respiratory rate MonitorChildren seen in triage in emergency department at SCH |
| General practice | – | Device: Contactless Portable Respiratory rate MonitorAdults or children attending general practice |
| Ambulance | – | Device: Contactless Portable Respiratory rate MonitorAdults or children in rapid response vehicle |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults or children requiring a respiratory rate measurement
Key inclusion criteria (1 listed)
- any person requiring and able to perform a respiratory rate measurement
Key exclusion criteria (2 listed)
- people assessed as too unwell to participate by clinical team
- people for whom English is not first language as no interpreting service included in budget
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 |
|---|---|---|
| Contactless Portable Respiratory rate MonitorAlso: "Breatheasy"Novel hand-held respiratory rate monitor | Device | Ambulance, Emergency department, General practice, School, Sleep unit |
Primary outcome
Correlation between the experimental technique and the gold standard (contact based thermistor system).
Time frame: Through study completion (less than 1 hour)
Correlation between device respiratory rate measurement of and measurement using respiratory impedance plethysmography will be examined.
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 21 Aug 2023.
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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.
Heather Elphick principal investigator
Investigator
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 Children, run by Sheffield Children's NHS Foundation Trust 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 1 inclusion and 2 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 21 Aug 2023. 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?
Correlation between the experimental technique and the gold standard (contact based thermistor system). (time frame: Through study completion (less than 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 21 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.