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

Recruiting

• Conditions: Focus of Study: Accurate Clinical Measurement and Diagnosis

• Registration Number: NCT05527990
• Lead Sponsor: PATH

Brief 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

Study Timeline

• Study Start: 2022-03-20
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observational implementation: multimodal (MM) operational feasibility	16 weeks	To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level.
Diagnostic accuracy: Performance of clinical measurement tools	19 weeks	To determine the performance of PPG-derived clinical measurement tools (medical device and smartphone-based screening technologies) compared to an accepted reference standard, among children 0-59 months seeking care at the primary care level.

Secondary Outcome Measures

Name	Time	Method
DA: Data repository	19 weeks	To create an open-source data repository for future research on PPG-derived clinical measurement tools for children.
DA: MM Usability	2 weeks	To measure the usability of multimodal PO devices, measuring pulse oximetry and respiratory rate in addition to other relevant clinical measurements, by healthcare providers at the primary care level.
OI: MM/clinical measurement system requirements	16 weeks	To explore future multimodal PO device and smartphone based clinical measurement product concepts and prototypes to further define the user and health system requirements for potential device integration within integrated management of childhood illness (IMCI) care practices, among country stakeholders and healthcare providers.
OI: MM co-design	1 week	To co-design integration of an approved multimodal PO device within existing IMCI practices, mapping current and future state workflows, prioritizing outcomes, and determining training needs.
DA: MM Acceptability	21 weeks	To assess the acceptability of multimodal PO devices among healthcare providers and caregivers at the primary care level.

Trial Locations

Locations (2)

Ngiri Health Center; 🇰🇪 Nairobi, Kenya

Mathare North Health Center; 🇰🇪 Nairobi, Kenya