Next-generation pulse oximeters for clinical measurement
A Study of Next-generation Pulse Oximeters to Support the Integrated Management of Childhood Illnesses in Primary Care Settings. A Mixed Methods Type 2 Effectiveness-implementation Study Measuring the Performance and Feasibility, of Multimodal Pulse Oximeter Devices by Primary Care Providers
This study is testing new pulse oximeters and smartphone tools to see if they can help doctors in Kenya, Senegal, Tanzania, and India better measure and diagnose breathing problems in young children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | N/A to 59 Months |
| Sex | All |
| Sponsor | Path Academic / other |
| Locations | 2 sites (Nairobi and 1 other locations) |
| Trial ID | NCT05527990 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and feasibility of next-generation photoplethysmograph (PPG)-derived clinical measurement tools, including medical devices and smartphone-based technologies, in primary care settings across Kenya, Senegal, Tanzania, and Uttar Pradesh, India. It employs a mixed methods approach, combining diagnostic accuracy assessments with implementation studies to gather data on usability, device performance, and caregiver/provider acceptability. The study aims to enhance clinical measurement and diagnosis of respiratory illnesses in young children by comparing these tools against established reference standards.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 59 months who are consulting for respiratory illnesses.
Not a fit: Patients who are critically ill, require emergency treatment, or are attending for trauma-related consultations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of clinical measurements and enhance the diagnosis of respiratory illnesses in young children.
How similar studies have performed: Other studies have shown success with similar diagnostic tools, indicating potential for effective implementation in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 0 - 59 months for whom caregivers provide consent to participate in the research study, following completion of clinical consultation * Consulting for a respiratory illness, or reported to have a respiratory illness when attending for a routine visit as an outpatient (e.g., vaccination, growth, or chronic disease monitoring) Exclusion Criteria: * Children in the immediate post-natal period or first day of life * Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds) * Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother) * Children who are critically ill, requiring emergency treatment, or received a recommendation of immediate referral during clinical consultation
Where this trial is running
Nairobi and 1 other locations
- Mathare North Health Center — Nairobi, Kenya (Recruiting)
- Ngiri Health Center — Nairobi, Kenya (Recruiting)
Study contacts
- Study coordinator: Helen Storey, PhD.
- Email: hstorey@path.org
- Phone: 510-541-4160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.