Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries

Study Overview
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Brief Summary
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This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.

Detailed Description
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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. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age. A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings. The aims of the study are to: to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications. to compare the usability of the redesigned oximeter probe to a market leading probe

Official Title
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Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries

Conditions
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Pneumonia in Children, Measurement of Peripheral Oxygen Saturation

Intervention / Treatment
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* Device: Pulse oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient participants: Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital, or government facilities in Malawi and Bangladesh Aged 0 - 59 months Clinically stable (as judged by the ward sister and medical team) Parent (or adult with parental responsibility) present Informed consent from the parent (or adult with parental responsibility) Healthcare worker participants: Nursing staff employed at Great Ormond Street Hospital who are trained in the use of pulse oximetry or government healthcare providers working in Malawi and Bangladesh Written informed consent from the healthcare worker Exclusion Criteria: Patient participants: Unstable or critically unwell patients (as judged by their medical team) Parents (or adult with parental responsibility) who are not able or willing to give informed consent Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form (UK only) For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded Healthcare worker participants: Healthcare providers who are not trained to use a pulse oximeter Healthcare providers who have not given written informed consent

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthcare worker measurement of SpO2<br>Measurement of SpO2 using the Lifebox pulse oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months | Device: Pulse oximeter<br>* Time taken to measure oxygen saturation. Completion of usability questionnaire<br>|
| Other: Expert measurement of SpO2<br>Measurement of SpO2 using the Lifebox pulse oximeter probe and Masimo oximeter probe in children of different ages, stratified by age: 0-1 months, 2-11 months, 12-23 months and 24-59 months | Device: Pulse oximeter<br>* Time taken to measure oxygen saturation. Completion of usability questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to obtain SpO2 reading | The time to obtain a stable reading will be declared by the healthcare worker or expert and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP). | Through completion of study, average one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulse oximetry, Children