Noncontact, Handheld Device for Measurement of Respiratory Rate (Breatheasy)

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.

Study Overview

• Status: Completed
• Conditions: Children
• Intervention / Treatment: Device: Contactless Portable Respiratory rate Monitor

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield (South Yorkshire District)
    • Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
      • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults or children requiring a respiratory rate measurement

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleep unit; Children admitted to sleep unit for sleep study	Device: Contactless Portable Respiratory rate Monitor; Novel hand-held respiratory rate monitor; Other Names: "Breatheasy"
School; Healthy children in school	Device: Contactless Portable Respiratory rate Monitor; Novel hand-held respiratory rate monitor; Other Names: "Breatheasy"
Emergency department; Children seen in triage in emergency department at SCH	Device: Contactless Portable Respiratory rate Monitor; Novel hand-held respiratory rate monitor; Other Names: "Breatheasy"
General practice; Adults or children attending general practice	Device: Contactless Portable Respiratory rate Monitor; Novel hand-held respiratory rate monitor; Other Names: "Breatheasy"
Ambulance; Adults or children in rapid response vehicle	Device: Contactless Portable Respiratory rate Monitor; Novel hand-held respiratory rate monitor; Other Names: "Breatheasy"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion (less than 1 hour)

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Collaborators: University of Sheffield; Sheffield Hallam University
• Investigators: Principal Investigator: Heather Elphick, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SCH/13/018