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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| University College, London | OTHER |
| PACHI Malawi - Parent and Child Health Initiative Trust | OTHER |
| Bill and Melinda Gates Foundation |
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This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter | Device | Time taken to measure oxygen saturation. Completion of usability questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Patient participants:
Healthcare worker participants:
Exclusion Criteria:
Patient participants:
Healthcare worker participants:
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| Name | Affiliation | Role |
|---|---|---|
| Isabeau A Walker, FRCA | Great Ormond Street Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylhet hospital | Sylhet | Bangladesh | ||||
| District and referral hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25552770 | Background | 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. | |
| 24738801 | 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. |
| Label | URL |
|---|---|
| Description of usability testing from the British Standards Institute | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2017 | Mar 5, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Consent | Oct 24, 2016 | Mar 5, 2018 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: HealthCare Worker Consent | Oct 24, 2016 | Mar 5, 2018 | ICF_002.pdf |
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| OTHER |
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| Lilongwe |
| Malawi |
| Great Ormond Street Hospital NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
| 25280870 | 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. |
| 18708248 | 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. |
| 23582723 | 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. |
| 18318953 | 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. |
| 22285055 | 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. |
| 20877714 | 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. |
| 14587545 | 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. |
| 29382679 | Derived | 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. |
| Guidance from British Standards Institute on best practices in usability testing | View source |