Lifebox Project
Research type
Research Study
Full title
Development of a robust and reliable pulse oximeter for use by frontline healthcare providers caring for children with pneumonia in low-income countries: clinical usability testing in children aged 0-59 months at Great Ormond Street Hospital, London
IRAS ID
211895
Contact name
Isabeau Walker
Contact email
Sponsor organisation
The Lifebox Foundation
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. Uptake of pulse oximetry in poorer countries is limited due to cost, durability and suitable design of pulse oximeters for children. The Lifebox Foundation has made significant progress in improving access to pulse oximetry in low-income countries. This project focuses on the design of a pulse oximeter for children.
The overall aim of this project is to improve the speed and reliability of the existing Lifebox pulse oximeter for children aged 0-59 months, and to design a novel oximeter probe that can be used by healthcare providers in all paediatric settings.
The specific aims of the study at Great Ormond Street Hospital (GOSH) are:
(1) to evaluate the function and usability of the Lifebox oximeter probe by an expert user (the Lifebox Fellow)
(2) to evaluate the function and usability of the oximeter probe by trained healthcare workers, against defined product specifications (the Target Product Profile, TPP).The study population will be the expert user/trained nurses assessing usability of the oximeter for children aged 0-59 months at GOSH. We will recruit patients from wards at GOSH who are clinically stable and experienced senior nurses. After obtaining informed consent, a trained observer will record demographic data, the clinical condition of the child and observe the time for the expert/nurses to obtain SpO2 readings. The users and observer will complete a usability questionnaire. All data recorded will be anonymised and recorded onto a portable tablet. We aim to conduct 360 measurements over a three-month period.
The study is conducted on behalf of the Lifebox Foundation, funded by the Bill and Melinda Gates Foundation.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/2208
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion