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Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services

NCT03750747 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2022-03-31

No results posted yet for this study

Summary

The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). The investigators will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities (phase 2).

This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH\&FWC) will be randomly assigned to comparison and intervention facilities.

Conditions

  • Childhood Pneumonia
  • Hypoxemia

Interventions

DEVICE

Pulse Oximeter

SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing \<10 kg, the sensor will be placed on the big toe. For patients weighing \>10 kg, the sensor will be placed on an index finger. In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt). First, the sensor will be placed on toe or index finger and then the PO will be powered-on. A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal). Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Ahmed Ehsanur Rahman, MBBS, MPH · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750747 on ClinicalTrials.gov