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

March 7, 2023 updated by: Isabeau Walker, The Lifebox Foundation

Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

572

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Sylhet, Bangladesh
        • Sylhet hospital
  • Malawi
      • Lilongwe, Malawi
        • District and referral hospitals
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabeau A Walker, FRCA
        • Sub-Investigator:
          • Nicholas Boyd, FRCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthcare worker measurement of SpO2
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

Time taken to measure oxygen saturation.

Completion of usability questionnaire
Other: Expert measurement of SpO2
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

Time taken to measure oxygen saturation.

Completion of usability questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through completion of study, average one hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, average one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lifebox Foundation

Collaborators

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

Investigators

  • Principal Investigator: Isabeau A Walker, FRCA, Great Ormond Street Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

October 16, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPP1133291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Yes. De-identified individual participant data for all primary and secondary outcomes will be made available for all study participants within 6 months of study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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