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NCT Number: NCT02941237

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

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

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Key information

Conditions

Pneumonia in Children Measurement of Peripheral Oxygen Saturation

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sylhet hospital, Sylhet, Bangladesh

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Oximeter

Device

Time taken to measure oxygen saturation.

Completion of usability questionnaire

Primary outcomes

  1. Time to obtain SpO2 reading

    Time frame: 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 outcomes

  1. Usability questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Lifebox Foundation

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Johns Hopkins University
  • PACHI Malawi - Parent and Child Health Initiative Trust
  • University College, London

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 21, 2016
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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