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

Sponsor
The Lifebox Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT02941237
Collaborator
Johns Hopkins University (Other), University College, London (Other), PACHI Malawi - Parent and Child Health Initiative Trust (Other), Bill and Melinda Gates Foundation (Other)
180
Enrollment
1
Location
2
Arms
3
Duration (Months)
60.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Pulse oximeter
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2017
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

  1. 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 and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP).

Other Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Patient participants:

  • Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital

  • Aged 0 - 59 months

  • Clinically stable (as judged by the ward sister and medical team)

  • Parent (or adult with parental responsibility) present

  • Written 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

  • Written informed consent from the healthcare worker

Exclusion Criteria:
Patient participants:

  • Unstable or critically unwell patients (as judged by the ward sister and 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

  • 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:

  • Nursing staff who are not trained to use a pulse oximeter

  • Nursing staff who have not given written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Great Ormond Street Hospital NHS Foundation Trust London United Kingdom WC1N 3JH

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Isabeau Walker, Consultant Paediatric Anaesthetist, Honorary Senior Lecturer, Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02941237
Other Study ID Numbers:
  • OPP1133291
First Posted:
Oct 21, 2016
Last Update Posted:
Oct 24, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Isabeau Walker, Consultant Paediatric Anaesthetist, Honorary Senior Lecturer, Great Ormond Street Hospital for Children NHS Foundation Trust
Pulse oximetry
Children
Additional relevant MeSH terms:
Pneumonia

Study Results

No Results Posted as of Oct 24, 2016