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

Pneumonia in Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941237
• Other study ID #: OPP1133291
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2023
• Source: The Lifebox Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: June 1, 2018
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Measurement of Peripheral Oxygen Saturation
• Pneumonia
• Pneumonia in Children

Intervention

Device:
• Pulse oximeter
Time taken to measure oxygen saturation. Completion of usability questionnaire

Locations

Country	Name	City	State
Bangladesh	Sylhet hospital	Sylhet
Malawi	District and referral hospitals	Lilongwe
United Kingdom	Great Ormond Street Hospital NHS Foundation Trust	London

Sponsors (5)

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

Countries where clinical trial is conducted

Bangladesh,  Malawi,  United Kingdom, 

References & Publications (9)

Bhutta ZA, Das JK, Walker N, Rizvi A, Campbell H, Rudan I, Black RE; Lancet Diarrhoea and Pneumonia Interventions Study Group. Interventions to address deaths from childhood pneumonia and diarrhoea equitably: what works and at what cost? Lancet. 2013 Apr 20;381(9875):1417-1429. doi: 10.1016/S0140-6736(13)60648-0. Epub 2013 Apr 12. — View 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. — View Citation

Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15. — View 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. — View 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. — View Citation

Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30. Erratum In: Lancet. 2015 Jan 31;385(9966):420. Lancet. 2016 Jun 18;387(10037):2506. — View Citation

Matai S, Peel D, Wandi F, Jonathan M, Subhi R, Duke T. Implementing an oxygen programme in hospitals in Papua New Guinea. Ann Trop Paediatr. 2008 Mar;28(1):71-8. doi: 10.1179/146532808X270716. — View Citation

Soofi S, Ahmed S, Fox MP, MacLeod WB, Thea DM, Qazi SA, Bhutta ZA. Effectiveness of community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Matiari district, rural Pakistan: a cluster-randomised controlled trial. Lancet. 2012 Feb 25;379(9817):729-37. doi: 10.1016/S0140-6736(11)61714-5. Epub 2012 Jan 27. — View Citation

Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability questionnaire	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
Primary	Time to obtain SpO2 reading	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

External Links

•   Description of usability testing from the British Standards Institute
•   Field guide to Human Centered Design by the design company 'IDEO' (IDEO.org)