It’s been a busy first week getting settled in Blantyre and at Queens, and things are already off to a great start! Tanya and I have spent the first few days getting to know our way around the hospital wards, meeting clinicians and nurses, and working at the bCPAP Office.
When it was first introduced at Queens in 2012, initial results showed that the bCPAP improved survival rates of neonates in respiratory distress to almost the same degree that the introduction of CPAP in the US did in the 1970s. The device, designed by a group of Rice bioengineering students in 2010, offers a low-cost alternative to CPAPs commercially available in the US, and the technology is currently being rolled out to all district hospitals in Malawi as well as into Tanzania, Zambia, and South Africa.
A large part of the technology implementation involves ongoing data collection and monitoring of all of the patients who are treated using bCPAP. This data includes important details such as primary diagnoses, duration of treatment, outcomes, and most recently, admission temperatures. Each of these factors plays a role in understanding not only how the technology is performing, but also whether or not it is being used appropriately and if additional treatment considerations could help improve outcomes.
For example, outcomes of bCPAP treated patients compared to outcomes of O2 treated patients may show us how the device is performing at a baseline level, but looking at primary diagnoses of patients helps us to understand how clinicians and nurses are selecting patients for bCPAP treatment and whether or not these are the patients that would benefit most from the treatment. Sometimes, patients with birth asphyxia are treated with CPAP, but complications associated with this condition would not be improved by CPAP assistance, so a poor outcome for these patients would not necessarily mean that the bCPAP is performing inadequately. Similarly, after monitoring patient outcomes across several seasons, data showed that during winter months, survival rates of bCPAP patients decreased. This observation led to the current project of collecting admission temperature data for all patients in order to analyze how variations in core body temperature affect treatment outcomes, and that’s one of the projects that Tanya and I will be helping with throughout the summer. Collecting this type of data can help determine what kinds of additional treatment considerations, such as maintaining stable core body temperatures, can further improve outcomes for bCPAP patients.
Within just the first few days of interacting with the CPAP study, I’ve gained a much greater appreciation for the amount of attention and scope of analysis required of clinical trials on medical devices. Contextualizing a device’s performance becomes critical in finding tangible ways to continually improve both implementation and design, and these improvements are essential for a device to remain relevant and effective.