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Tools for the Integrated Management of Childhood Illness

A hybrid type-2 study of next generation pulse oximeters to support the integrated management of childhood illnesses in primary care settings.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052727
Enrollment
4200
Registered
2023-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: X- New Technology

Interventions

Intervention1: Use of PPG based non-invasive devices to measure SpO2, pulse rate, respiratory rate, temperature and haemoglobin as per device functionalities.: Rad-G Temp, m800, Scanbo v8, Onyx PO+RR,

Sponsors

PATH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children 0 â?? 59 months for whom caregivers provide consent to participate in research study, following completion of clinical consultation 2. 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

Exclusion criteria: 1. Children in the immediate post-natal period or first day of life 2. Attending for a consultation related to trauma only (including new and follow up presentations for burns, injuries, wounds) 3. Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother) 4. Children who are critically ill, requiring emergency treatment, or received a recommendation of immediate referral during clinical consultation

Design outcomes

Primary

MeasureTime frame
Outcomes of performance and usability by primary care providers including: Agreement of each clinical measurement comparing the index test device to the reference standard, error rates with minor/major/critical errors classified, pass rates, ease of use and user confidence ratings, and system usability score.Timepoint: 6 months

Secondary

MeasureTime frame
The secondary outcome on feasibility will be finalized in the co-design workshop and may include elements of acceptability, uptake, appropriateness, cost, fidelity, and penetration/reach.Timepoint: 4 months

Countries

India

Contacts

Public ContactShally Awasthi

King Georges Medical University

shally07@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026