Clinical trial NCT04215887: Noncontact, Handheld Device for Measurement of Respiratory Rate
Official title: Development of the "BreathEasy": a Non-contact, Hand-held Device for Measurement of Respiratory Rate (CPRM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
name: University of Sheffield
First posted: 2020-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults or children requiring a respiratory rate measurement

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* any person requiring and able to perform a respiratory rate measurement

Exclusion Criteria:

* 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

Primary outcomes:
measure: Correlation between the experimental technique and the gold standard (contact based thermistor system).
timeFrame: Through study completion (less than 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire District)
Study officials:
affiliation: Investigator
name: Heather Elphick
role: PRINCIPAL_INVESTIGATOR
References: