Evaluation of the "Breatheasy" in Pre-hospital Care

January 3, 2020 updated by: Sheffield Children's NHS Foundation Trust

Evaluation and Validation of the "Breatheasy" Respiratory Rate Monitor in Pre-hospital Care

In the emergency department, a sick child is usually seen first by the nursing staff. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use suitable devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, normally the respiratory rate has to be manually counted (this is the average number of breaths taken each minute) because there is no suitable device which can automatically do this assessment. To overcome this problem we have produced a noncontact device that can automatically measure respiratory rate in children. The device has been designed using the latest technology and works by directly sensing the air coming from the nose or the mouth when held at about 20 cm from the face. It has been tested on adults and children and compared to the usual methods of measuring respiratory rate. We have used comments and Suggestions from members of the public and healthcare professionals from hospital, general practice and the ambulance service to help us develop the device. With this study, we explore the applicability and usefulness of the device in a range of difference clinical and nonclinical settings. Its performance will be carefully evaluated on children and adults in children's nurseries, schools, university, hospital emergency departments, general practice surgeries and ambulances. In the future, when using the device nursing staff will easily be able to measure each child's respiratory 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, deaths will be prevented.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Any adult or child within each setting, of any age with any clinical condition, as this will reflect clinical practice.

Exclusion Criteria:

  • Patients deemed too unwell to consent to the procedures or requiring emergency treatment will not be approached.
  • For the purposes of this feasibility study, families whose first language is not English will be excluded, to save translation and interpretation costs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Breathing test or sleep study
To evaluate the usability of the device in non-clinical and clinical settings
Device: Breatheasy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate using the prototype device
Time Frame: 5 minutes
In the future, when using the device nursing staff will easily be able to measure each child's respiratory rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SCH-15-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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