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 Type
OBSERVATIONAL
Enrollment
3,149
The Hospital for Sick Children
Toronto, Ontario, Canada
Aga Khan University
Karachi, Pakistan
Prevalence of hypoxemia
Time frame: Over the duration of hopsital stay, on average 24 hours
Validity of PO
Validity of PO for the detection of infant illness, in comparison to physician assessment.
Time frame: Baseline, +2 hours
Comparison of PO Measurements
Between-devices comparison of PO measurements
Time frame: Baseline, +2 hours
Operational Feasibility
Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
Time frame: Baseline, +2 hours
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