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

Not Applicable

Completed

• Conditions: Pneumonia in Children; Measurement of Peripheral Oxygen Saturation

• Registration Number: NCT02941237
• Lead Sponsor: The Lifebox Foundation

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

Study Timeline

• Study First Submitted: 2016-10-16
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2017-05-02
• Primary Completion: 2017-06-02
• Study Completion: 2018-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 572

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Sylhet hospital; 🇧🇩 Sylhet, Bangladesh

District and referral hospitals; 🇲🇼 Lilongwe, Malawi

Great Ormond Street Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom