NCT02941237

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: The Lifebox Foundation · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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

Conditions

• Pneumonia in Children
• Measurement of Peripheral Oxygen Saturation

Interventions

Type	Name	Description
DEVICE	Pulse oximeter	Time taken to measure oxygen saturation. Completion of usability questionnaire

Timeline

• Start date: 2017-05-02
• Primary completion: 2017-06-02
• Completion: 2018-06-01
• First posted: 2016-10-21
• Last updated: 2023-03-09

Locations

3 sites across 3 countries: Bangladesh, Malawi, United Kingdom