Background Thoracic trauma accounts for 10% to 15% of trauma-related hospital admissions and contributes significantly to morbidity and mortality. Rib fractures, the most common thoracic injury, often result in pulmonary complications such as pneumonia and atelectasis due to impaired respiratory mechanics. Incentive spirometry (IS) is a widely used noninvasive technique aimed at improving pulmonary function after injury, yet patient compliance remains a challenge. Gamification of respiratory therapy has emerged as a promising approach to enhance engagement and adherence. Objective This paper presents the protocol for a study to evaluate the feasibility and safety of using gamified IS through the OmniFlow Breathing Therapy BioFeedback System in trauma patients. While preliminary observations related to potential clinical efficacy (eg, respiratory function and adherence) are of interest, structured clinical or physiological end points are not included in this protocol for a pilot study and are planned for future trials. Methods This protocol is for a single-center, prospective, observational phase 2 pilot study to be conducted at Wake Forest Baptist Medical Center. Adult patients (aged ≥18 years) admitted to the trauma intensive care unit with rib fractures and a Glasgow Coma Scale score of 15 are eligible for inclusion if their first intervention session can occur within 48 hours of admission. Patients requiring mechanical ventilation, those with baseline lung disease, and those with contraindications to IS are excluded. Enrolled patients participate in at least one gamified respiratory therapy session daily, lasting 15 to 20 minutes, with the possibility of additional sessions based on patient preference and tolerance. Primary end points include the feasibility of enrolling 20 patients and their participation in at least one session. Secondary end points evaluate patient adherence, number of completed sessions, and session interruptions due to predefined safety criteria (eg, pain score >8/10, oxygen desaturation <92%, new cardiac arrhythmia, or respiratory distress). If 5 consecutive patients fail to complete a session due to adverse events, the intervention is deemed unsafe. Results The study was approved by the institutional review board of Atrium Health Wake Forest Baptist Medical Center and was registered at ClinicalTrials.gov. However, no participants were ever enrolled, as the OmniFlow partners did not supply the device for the study. Despite this, it remains a potentially beneficial tool, and future studies may confirm its benefits once the device becomes available. Conclusions OmniFlow offers a promising, much-needed solution for promoting adherence to breathing exercises among patients with thoracic trauma. This study protocol is designed to evaluate its safety and feasibility in patients with thoracic trauma and rib fractures. Looking ahead, incorporating multiplayer games into the platform could further enhance its effectiveness, allowing patients to engage in group activities while working toward their individual therapeutic goals. International Registered Report Identifier (IRRID) PRR1-10.2196/75871
Al-Dhoon et al. (Fri,) studied this question.