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

PATH

Status: Enrolling

Conditions: Focus of Study: Accurate Clinical Measurement and Diagnosis

Treatments: Device: Multimodal PO

Study type: Observational

Funder types: Other

Identifiers

NCT05527990

RES-00317

Details and patient eligibility

About

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.

Full 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

Enrollment: 650 estimated patients

Sex: All

Ages: Under 59 months old

Volunteers: No Healthy Volunteers

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