NCT05527990

TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 59 Months
• Healthy volunteers: Not accepted

Summary

This study aims to provide evidence on next-generation clinical measurement tools through a mixed methods diagnostic accuracy and implementation study in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.

Detailed description

Performance and feasibility of photoplethysmograph (PPG)-derived clinical measurement tools (medical device and smartphone-based screening technologies) by primary care providers will be assessed using a type 2 hybrid design to conduct a mixed methods diagnostic accuracy and implementation study. The diagnostic accuracy study will consist of 3 components to achieve the primary and secondary objectives: 1) a usability assessment of observed user-product interactions and a system usability score, 2) measurement of multimodal PO device performance through comparison against a reference standard, and 3) caregiver/provider acceptability through semi-structured interviews. The observational implementation (OI) study consists of 3 components to achieve the primary and secondary objectives: 1) a human-centered design workshop, 2) an observational study to evaluate the feasibility of implementing an approved multimodal PO device in clinical care, and 3) semi-structured in-depth interviews to assess provider and caregiver acceptability and adaptation. The interventions for this study are PPG-derived clinical measurement tools that measure oxygen saturation (SpO2), pulse rate, respiratory rate, and/or temperature. The interventions will also be compared to a reference standard for the different clinical measurements

Conditions

• Focus of Study: Accurate Clinical Measurement and Diagnosis

Interventions

Type	Name	Description
DEVICE	Multimodal PO	Mixed methods diagnostic accuracy and implementation of multimodal PO

Timeline

• Start date: 2022-03-20
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-09-06
• Last updated: 2023-10-26

Locations

2 sites across 1 country: Kenya

Regulatory

• FDA-regulated device study