Clinical trial NCT02941237: Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia in Children
Measurement of Peripheral Oxygen Saturation
Keywords: Pulse oximetry
Children
Lead sponsor: The Lifebox Foundation
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University College, London
name: PACHI Malawi - Parent and Child Health Initiative Trust
name: Bill and Melinda Gates Foundation
First posted: 2016-10-21
Enrollment: 572
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to obtain SpO2 reading
timeFrame: Through completion of study, average one hour
Secondary outcomes:
Other outcomes:
measure: Usability questionnaire
timeFrame: Through study completion, average one hour
Locations:
city: Sylhet
country: Bangladesh
facility: Sylhet hospital
city: Lilongwe
country: Malawi
facility: District and referral hospitals
city: London
country: United Kingdom
facility: Great Ormond Street Hospital NHS Foundation Trust
Study officials:
affiliation: Great Ormond Street Hospital NHS Foundation Trust
name: Isabeau A Walker, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burn SL, Chilton PJ, Gawande AA, Lilford RJ. Peri-operative pulse oximetry in low-income countries: a cost-effectiveness analysis. Bull World Health Organ. 2014 Dec 1;92(12):858-67. doi: 10.2471/BLT.14.137315. Epub 2014 Sep 24.
citation: Finch LC, Kim RY, Ttendo S, Kiwanuka JK, Walker IA, Wilson IH, Weiser TG, Berry WR, Gawande AA. Evaluation of a large-scale donation of Lifebox pulse oximeters to non-physician anaesthetists in Uganda. Anaesthesia. 2014 May;69(5):445-51. doi: 10.1111/anae.12632.
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citation: Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003 Aug;35(3):379-83. doi: 10.3758/bf03195514.
citation: King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177.