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Evaluation of pulse oximetry and clinical decision support algorithms in primary care.

Tools for the integrated management of childhood illness evaluation of pulse oximetry and clinical decision support algorithms in primary care pragmatic cluster randomized controlled trial, with embedded mixed methods, cost and cost-effectiveness studies in India and Tanzania

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041325
Enrollment
172080
Registered
2022-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: R69- Illness, unspecified

Interventions

Intervention1: Clinical Decision Support Algorithm (CDSA) and Pulse oximeter.: Arm 1 - CDSA + Pulse Oximeter. CDSA will be used during the consultation. Pulse oximetry will be performed and Spo2 level

Sponsors

PATH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with illness 2. Children of whose caregivers provide consent.

Exclusion criteria

Exclusion criteria: 1. Inpatients 2. Children attending facility with Trauma and Immunization.

Design outcomes

Primary

MeasureTime frame
Two primary outcomes will be assessed in order to improve the ability to detect a difference between each of the intervention arms and the control arm, given the relatively low occurrence of severe outcomes at primary care level: â?¢ Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7 â?¢ Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referralTimepoint: Day 7 - Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7 24 hours - Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referral

Secondary

MeasureTime frame
â?¢ Proportion of children with severe complication (death or secondary hospitalisation) by Day 28 â?¢ Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7 â?¢ Proportion of children referred by a primary care healthcare provider to a higher level of care (either to a hospital or to an inpatient part of a larger primary healthcare facility) at Day 0 consultationTimepoint: Day 28 Day 7 Day 0

Countries

India, Kenya, Myanmar, Senegal, Tanzania

Contacts

Public ContactProf Shally Awasthi

King Georges Medical University

shally07@gmail.com09839221244

Outcome results

None listed

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