Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Cou… (NCT02941237) | Clinical Trial Compass
CompletedNot Applicable
Development of a Robust and Reliable Pulse Oximeter for Children With Pneumonia in Low-income Countries
Bangladesh, Malawi, United Kingdom572 participantsStarted 2017-05-02
Plain-language summary
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
Who can participate
Age range5 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time to obtain SpO2 reading
Timeframe: Through completion of study, average one hour