Noncontact, Handheld Device for Measurement of Respiratory Rate

NCT ID: NCT04215887

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-16

Study Completion Date

2015-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep unit

Children admitted to sleep unit for sleep study

Contactless Portable Respiratory rate Monitor

Intervention Type DEVICE

Novel hand-held respiratory rate monitor

School

Healthy children in school

Contactless Portable Respiratory rate Monitor

Intervention Type DEVICE

Novel hand-held respiratory rate monitor

Emergency department

Children seen in triage in emergency department at SCH

Contactless Portable Respiratory rate Monitor

Intervention Type DEVICE

Novel hand-held respiratory rate monitor

General practice

Adults or children attending general practice

Contactless Portable Respiratory rate Monitor

Intervention Type DEVICE

Novel hand-held respiratory rate monitor

Ambulance

Adults or children in rapid response vehicle

Contactless Portable Respiratory rate Monitor

Intervention Type DEVICE

Novel hand-held respiratory rate monitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contactless Portable Respiratory rate Monitor

Novel hand-held respiratory rate monitor

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

"Breatheasy"

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role lead

Sheffield Hallam University

OTHER

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Elphick

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCH/13/018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The PneumoRator Study
NCT07293299 RECRUITING
Pulse Oximetry Performance Comparison in Newborns
NCT06637917 ACTIVE_NOT_RECRUITING