Infant Pulse Oximetry in Pakistan Study (iPOP)
Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting. In this research study, we propose to test the hypothesis that the use of pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible for the identification of the infants most urgently in need of medical care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi. Infants will undergo brief clinical assessment by a community health worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician. The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain measurement, number of infants for who repeat measurements are required), and concordance between paired measurements on separate devices.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Infant Pulse Oximetry in Pakistan (iPOP) Study: Utility and Feasibility of Integrating Pulse Oximetry Into the Routine Assessment of Young Infants at First-level Clinics in Karachi, Pakistan|
- Prevalence of hypoxemia [ Time Frame: Over the duration of hopsital stay, on average 24 hours ] [ Designated as safety issue: No ]
- Validity of PO [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]Validity of PO for the detection of infant illness, in comparison to physician assessment.
- Comparison of PO Measurements [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]Between-devices comparison of PO measurements
- Operational Feasibility [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
|Study Start Date:||January 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Infants presenting to the Clinic
Infants presenting to the Bilal and Bhains Colony Health Center. Devices used to measure Pulse Oximetry (PO) include Rad-5v by Masimo, TuffSat by GE, N-65 by Nellcor, PRO2 by Conmed, and Lifebox by Acare.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676610
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Aga Khan University|
|Principal Investigator:||Daniel Roth, MD||The Hospital for Sick Children|