JMIR Publications

ABSTRACT

Background:

Pectus excavatum (PE) is the most common congenital chest wall deformity, corrected during adolescence using minimally invasive techniques (MIRPE). Cryoanalgesia has emerged as a valuable adjunct in reducing pain, opioid consumption, and hospital stay. Since recovery trajectories vary widely among patients, we hypothesized that integrating clinical and wearable-derived digital data may allow early identification of recovery patterns and functional improvement following MIRPE.

Objective:

This study was a proof of concept to test the hypothesis that continuous pre- and post-operative parameters collected via wearable devices may provide a personalized approach for identifying recovery patterns or early signs of complications.

Methods:

We designed a feasibility randomized controlled trial in patients undergoing MIRPE, assigned to either cryoanalgesia or thoracic epidural analgesia. All patients were invited to wear a Fitbit Sense 2 device, and digital data were recorded continuously and stored in a dedicated database. Clinical data were entered in REDCap electronic data capture tools by clinicians or through the MyCap mobile app by patients. The study aimed to assess patient compliance with wearing the device and the feasibility of integrating wearable-derived biometric data with clinical variables in adolescents undergoing MIRPE with cryo- or epidural analgesia. Reporting follows the CONSORT 2010 extension to randomized pilot and feasibility trials.

Results:

Patients in the cryoanalgesia group demonstrated higher compliance with wearing their devices during the day and at night throughout the study period, and higher average step counts, compared to the epidural group. Differences between groups were not statistically significant (P values > .05) regarding the Pediatric Quality of Life Inventory (PedsQL™). By the end of the study both groups followed similar recovery trends. Occurrence of complications was early detected by digital data through wearable devices.

Conclusions:

This proof-of-concept trial confirms that retention and compliance are crucial for the success of the second trial phase. Leveraging Fitbit-derived data may enable a personalized pain management approach with early detection of complications. The benefits of cryoanalgesia in terms of health-related quality of life, as assessed by subjective scales, did not differ significantly from those of the standard of care (epidural–based analgesia); however, the present sample size does not allow a formal claim of equivalence. Continuous biometric data provided a more personalized follow-up. Clinical Trial: Ethical approval was obtained from the Institutional Review Board at Istituto Giannina Gaslini (approval number: 278/2021 – DB id 11421; NCT number: NCT0520182041). All procedures were conducted in accordance with the Declaration of Helsinki.