Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries
NCT ID: NCT02941237
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
572 participants
INTERVENTIONAL
2017-05-02
2018-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services
NCT03750747
Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device
NCT05175612
Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia
NCT05239559
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
NCT04253834
TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters
NCT05527990
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Pulse oximeter
Time taken to measure oxygen saturation.
Completion of usability questionnaire
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
Pulse oximeter
Time taken to measure oxygen saturation.
Completion of usability questionnaire
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulse oximeter
Time taken to measure oxygen saturation.
Completion of usability questionnaire
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
5 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johns Hopkins University
OTHER
University College, London
OTHER
PACHI Malawi - Parent and Child Health Initiative Trust
OTHER
Bill and Melinda Gates Foundation
OTHER
The Lifebox Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isabeau Walker
Consultant Paediatric Anaesthetist, Honorary Senior Lecturer Great Ormond Street Hospital NHS Foundation Trust
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabeau A Walker, FRCA
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Hospital NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sylhet hospital
Sylhet, , Bangladesh
District and referral hospitals
Lilongwe, , Malawi
Great Ormond Street Hospital NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Parent Consent
Document Type: Informed Consent Form: HealthCare Worker Consent
Related Links
Access external resources that provide additional context or updates about the study.
Description of usability testing from the British Standards Institute
Guidance from British Standards Institute on best practices in usability testing
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OPP1133291
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.