Measurement of Peripheral Oxygen Saturation, Pneumonia in Children
Conditions
Keywords
Pulse oximetry, Children
Brief summary
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
Detailed description
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: 1. to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user 2. to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications. 3. to compare the usability of the redesigned oximeter probe to a market leading probe
Interventions
DEVICEPulse oximeter
Time taken to measure oxygen saturation. Completion of usability questionnaire
Sponsors
Johns Hopkins University
University College, London
PACHI Malawi - Parent and Child Health Initiative Trust
Bill and Melinda Gates Foundation
The Lifebox Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to obtain SpO2 reading | Through completion of study, average one hour | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability questionnaire | Through study completion, average one hour | Healthcare workers and the expert user will complete a usability questionnaire after completion of readings in children of different ages |
Countries
Bangladesh, Malawi, United Kingdom
Outcome results
None listed