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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

February 16, 2015

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed

3.8 years until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed

Last Updated

August 21, 2023

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

April 1, 2016

Last Update Submit

August 16, 2023

Conditions

Children

Outcome Measures

Primary Outcomes (1)

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)