Noncontact, Handheld Device for Measurement of Respiratory Rate

Children Clinical Trial

— Breatheasy  

Official title:

Development of the "BreathEasy": a Non-contact, Hand-held Device for Measurement of Respiratory Rate (CPRM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215887
• Other study ID #: SCH/13/018
• Status: Completed
• Start date: February 16, 2015
• Est. completion date: November 1, 2015

Study information

• Verified date: December 2019
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Children

Intervention

Device:
• Contactless Portable Respiratory rate Monitor
Novel hand-held respiratory rate monitor

Locations

Country	Name	City	State
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	Sheffield (South Yorkshire District)

Sponsors (3)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust	Sheffield Hallam University, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)