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Completed

NCT Number: NCT04215887

Noncontact, Handheld Device for Measurement of Respiratory Rate

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.

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Key information

Conditions

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contactless Portable Respiratory rate Monitor

Device

Novel hand-held respiratory rate monitor

Other names: "Breatheasy"

Primary outcomes

  1. Correlation between the experimental technique and the gold standard (contact based thermistor system).

    Time frame: Through study completion (less than 1 hour)

    Correlation between device respiratory rate measurement of and measurement using respiratory impedance plethysmography will be examined.

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University
  • University of Sheffield

Registry information

Official study title

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

Acronym: Breatheasy

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 2, 2020
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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