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

NCT02941237 | Completed

• 1 other identifier: OPP1133291
• Study Type: interventional
• Target: 572
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Pneumonia in Children; Measurement of Peripheral Oxygen Saturation

Keywords

Pulse oximetry; Children

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Usability questionnaire

  Through study completion, average one hour

Study Arms (2)

Healthcare worker measurement of SpO2

OTHER

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

Expert measurement of SpO2

OTHER

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

Interventions

Pulse oximeter DEVICE

Time taken to measure oxygen saturation. Completion of usability questionnaire

Expert measurement of SpO2; Healthcare worker measurement of SpO2

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Sylhet hospital

Sylhet, Bangladesh

Location

District and referral hospitals

Lilongwe, Malawi

Location

Great Ormond Street Hospital NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 25552770 BACKGROUND

• 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.

  PMID: 24738801 BACKGROUND

• 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.

  PMID: 25280870 BACKGROUND

• 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.

  PMID: 18708248 BACKGROUND

• 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.

  PMID: 23582723 BACKGROUND

• 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.

  PMID: 18318953 BACKGROUND

• 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.

  PMID: 22285055 BACKGROUND

• 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.

  PMID: 20877714 BACKGROUND

• 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.

  PMID: 14587545 BACKGROUND

• 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.

  PMID: 29382679 DERIVED

Related Links

• Description of usability testing from the British Standards Institute
• Guidance from British Standards Institute on best practices in usability testing

Study Officials

• Isabeau A Walker, FRCA

  Great Ormond Street Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Paediatric Anaesthetist, Honorary Senior Lecturer Great Ormond Street Hospital NHS Foundation Trust

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 21, 2016
• Study Start: May 2, 2017
• Primary Completion: June 2, 2017
• Study Completion: June 1, 2018
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); MA (1); GB (1)