Gamification of Incentive Spirometry in Trauma Patients: Protocol for a Prospective, Observational Feasibility Study

Introduction

Thoracic trauma is encountered in 10% to 15% of all trauma-related hospital admissions and has been cited as causing 35% of all trauma-related deaths in the United States. Between 2010 and 2016, over 500,000 trauma patients were diagnosed with at least one rib fracture in the United States [1]. Traumatic rib fractures are the most common thoracic trauma and are associated with significant morbidity, mortality, and decreased long-term quality of life. Fractured ribs are present in approximately 20% of patients admitted to trauma centers with blunt chest trauma [2]. Thoracic trauma causes increased splinting of the chest muscles due to pain, causing increasing incidence of pulmonary complications like pneumonia, atelectasis, and acute respiratory failure. Rib fracture pain and disability can be a serious impediment to returning to work. Mortality rates of up to 33% have been reported for flail chest injury [3].

The mortality rate associated with chest trauma involving rib fractures is estimated to be approximately 10%, with the risk increasing with the number of fractured ribs, reaching nearly 40% in patients with more than 6 fractures [4]. Pulmonary complications remain a leading cause of death in these cases. Numerous strategies have been used to reduce pulmonary complications following chest trauma, such as surgical stabilization of rib fractures and multimodal analgesia, including epidural anesthesia. However, these techniques are invasive and may not be practical in all cases [5]. Physiotherapy has been considered a critical component in the postoperative recovery of these patients. Specifically, airway clearance techniques, including instruction on breathing exercises aimed at reducing the effects of atelectasis, have been demonstrated to significantly lower the incidence of postoperative pulmonary complications. Incentive spirometry (IS) is a method that enables patients to perform deep breathing exercises autonomously, providing visual feedback on inspiratory effort. This technique is believed to enhance the precision of deep breathing exercises and to motivate patients to engage consistently in these exercises [6]. While it reduces pulmonary complications [7], low patient compliance has prompted the need for innovative strategies to increase patient engagement and motivate patients to engage in breathing exercises while offering quantitative measurements of their progress and adherence.

Emerging efforts have focused on gamification of pulmonary rehabilitation through game-based IS in patients with chest trauma to prevent pulmonary complications. Previously, a game was developed to enhance breathing exercises in which users control an airplane with their breath and guide a bird through scenic landscapes, accompanied by calming music. The game was tested on healthy individuals and received positive feedback [8]. A virtual IS application for smartphones called QUT Inspire has also been developed as an HTML5 web application [9]. This app uses the smartphone’s built-in microphone to detect inspiratory sounds, which in turn sustains a responsive animated graphic display as long as the breath sound is detected. A postresearch questionnaire showed that the majority of participants preferred the new virtual app for visualizing their inspirations. Despite promising preliminary results, these studies have enrolled either healthy volunteers or patients with specific lung pathologies, and there is a paucity of data regarding the gamification of respiratory therapy involving patients with trauma, specifically trauma to the thoracic cavity; nevertheless, such therapy has significant potential to benefit these patients by enabling increased respiratory therapy.

We designed this study to assess the safety and feasibility of a respiratory intervention in trauma patients with rib fractures using a gamification platform. Herein, we describe the study protocol for this study. While preliminary observations related to potential clinical efficacy (eg, respiratory function and adherence) are of interest, structured clinical or physiological end points were not included in this protocol and are planned for future trials.

Methods

This investigation entails a single-center, prospective, observational, pilot phase 2 study focusing on the primary objective of feasibility and safety of gamified respiratory therapy interventions among thoracic trauma patients. The study leverages the OmniFlow Breathing Therapy BioFeedback System as an evaluative tool for gauging the efficacy of gamified respiratory therapy interventions in thoracic trauma patients. The OmniFlow Breathing Therapy BioFeedback System uses a virtual environment (the OmniFlow system), a US Food and Drug Administration–approved health care gaming system that uses biofeedback mechanisms to assess and encourage thoracic trauma patients to achieve optimal breathing patterns essential for pulmonary recovery.

Participant Recruitment and Enrollment

In the study described by this protocol, all adult patients aged ≥18 years admitted for rib fractures to the trauma intensive care unit (ICU) at Wake Forest Baptist Medical Center are screened for the study and included if they have a Glasgow Coma Scale (GCS) score of 15, are willing to participate, and the first session of intervention can occur within 48 hours of admission. This feasibility study is designed to include a total of 20 consenting patients. Patients are excluded if they (1) require mechanical ventilation or bilevel positive airway pressure, (2) have a GCS score <15, (3) have facial fractures, (4) have baseline lung disease or use home oxygen, (5) have a physical disability or trauma impairing the use of IS, (6) are expected to be transferred or discharged within 24 hours of expected enrollment, as per the treating physicians’ judgment, (7) are transitioning to palliative care or are anticipated to die within the next 48 hours, (8) are unable to provide self-consent, and (9) are unable to use the mouthpiece of the OmniFlow System due to visual or hearing impairments.

The sample size of 20 participants was chosen based on feasibility study conventions, which recommend 12 to 30 participants to assess logistical and safety outcomes in early-phase research. We defined a successful outcome for feasibility as the ability to enroll 20 patients within the study timeframe and for at least 75% of these patients to complete one full session without interruption due to safety-related criteria.

Ethical Considerations

Eligible patients are approached by the investigators and study coordinators for detailed discussion of the study. Informed consent is sought to initiate the first session of the OmniFlow Breathing Therapy Biofeedback System within 48 hours of admission. The care team is consulted prior to deploying each session of the OmniFlow system to ensure that it is safe and does not interference with the patient’s care. Comprehensive information about the study, including session initiation timing, session frequency, game details, potential benefits, and risks associated with the OmniFlow Breathing Therapy BioFeedback System are communicated to the patients before obtaining consent. The protocol has been approved by the Atrium Health Wake Forest Baptist Medical Center institutional review board (IRB00097144) and registered at ClinicalTrials.gov (NCT06090279).

Privacy and Confidentiality

Participants’ privacy and confidentiality were carefully protected throughout the study. All data were de-identified and securely stored on password-protected systems accessible only to the research team. Personal identifiers were replaced with unique participant codes to ensure anonymity. No identifying information was included in any publications or shared datasets. All research personnel followed strict confidentiality protocols and HIPAA-compliant practices.

Compensation

No compensation was provided to participants. Their voluntary participation was based solely on willingness to contribute to the study without financial or material incentive.

Data Collection and Confidentiality Measures

Upon obtaining consent, patient-specific information such as name, medical record number, age, gender, weight, height, medical history, and current respiratory status and care are collected. Strict confidentiality measures are implemented, collecting only essential information for assessing study outcomes, minimizing identifiable data, and securely storing all study-related information. Unique study identifiers are used on data collection forms, with a separate, secure linkage file maintaining any patient-identifying information. Access to the linkage file is restricted to designated study personnel, and data access is granted solely to team members educated in Health Insurance Portability and Accountability Act practices. Physical and electronic records are secured, and participant descriptions in reports, presentations, or publications omit personal health identifiers, ensuring participant anonymity.

All instances of missed sessions, dropouts, or early discontinuation are recorded in the Research Electronic Data Capture (REDCap; Vanderbilt University) system with documentation of the underlying reason, including patient-reported barriers, clinical contraindications, or scheduling and logistical constraints. Partial adherence (eg, completing fewer than the recommended number of sessions) is also tracked. These data will be descriptively analyzed and categorized into thematic groups (eg, clinical deterioration, lack of interest, and device discomfort) to better understand patient engagement and barriers to full participation.

Given the exploratory nature of this pilot study and the limitations in anticipated enrollment, structured clinical or physiological efficacy end points (eg, pulmonary function, respiratory rate trends, or serial pain scores) were not predefined. These will be incorporated into future, larger-scale trials aimed at assessing the therapeutic impact of gamified IS more comprehensively.

Intervention

Patients commence the intervention with a regimen of at least two daily sessions, each anticipated to last 15 to 20 minutes. Should patients exhibit favorable tolerance and express a desire for additional sessions, an optimal dosage may involve an increase in the frequency of daily sessions. Conversely, if patients do not demonstrate a preference for the intervention, it may be inferred that gamified therapy is not the optimal therapeutic modality for them.

The session will be ended if one or more of the following termination criteria is met:

• Sustained pain score exceeding 8/10
• Elevated oxygen requirements surpassing an increment of 2 L/min from before the intervention or a decline in oxygen saturation below 92% during the intervention, necessitating the escalation of an oxygen supplementation device
• Sustained heart rate surpassing 110 beats per minute, accompanied by either a new cardiac arrhythmia or a respiratory rate exceeding 30 per minute
• Manifestation of cyanosis, pallor, or the onset of new confusion

All sessions are conducted at the bedside under the direct supervision of a trained study coordinator who monitors the patient’s vital signs and tolerance in real time using the hospital’s standard ICU monitoring systems (including pulse oximetry and telemetry). The session is immediately ended if there is any indication of distress or a breach of the predefined termination criteria. A bedside ICU nurse is notified prior to each session, and the clinical care team remains on standby to respond if needed. All adverse events or session interruptions are recorded in a REDCap database with detailed documentation of observed symptoms, vital sign trends, criteria met, time of termination, and any follow-up clinical actions.

Data Collected as Part of the Study

The primary end point of the study is the enrollment of 20 patients who consent to the study and participate in at least one session. The secondary end points of the study are the number of patients who do not complete any therapy sessions after initiation, and the number of sessions interrupted due to the above criteria. The safety end point of the study is if 5 consecutive patients do not complete a therapy session due to any of the above criteria.

In addition to the primary feasibility end point of 20 enrolled patients participating in at least one session, we also collect data on session adherence (total number of sessions completed per patient), tolerance (interruption of sessions due to predefined clinical criteria), and engagement (patient requests for additional sessions). These secondary indicators will provide a more comprehensive understanding of the intervention’s feasibility and acceptability.

Results

The study was approved by the institutional review board and registered on ClinicalTrials.gov. Due to an unexpected delay in the initiation of the project, no patients were enrolled.

Discussion

Overview

Much of a thoracic trauma patient’s hospitalization is focused on adverse outcome risk reduction through aggressive pulmonary therapies. Internal fixation of rib fractures and multimodal analgesia, including epidural anesthesia, have been found to be effective in preventing pulmonary complications. However, these techniques are invasive and may not be practical in all cases [10]. Breathing exercises and physiotherapy serve as noninvasive alternatives, with IS being one of the most commonly used modalities. IS was developed in the 1970s to encourage patients to repeatedly and gradually increase inspiratory volumes in an effort to avoid alveolar atelectasis [11]. It serves as a simple, easy-to-teach modality that promotes deep inhalation and mucous clearance (9). For alert and motivated patients, IS can be self-driven and used frequently, and it has been shown to improve lower airway patency, lung compliance, oxygenation, and maximal inhalation capacity. IS forces patients to take long, deep breaths and hold them for a few seconds to facilitate the clearing of secretions by reducing breathing effort, minimizing the use of accessory muscles, and opening the alveoli.

Multiple studies have demonstrated the benefits of IS use. For example, in a study involving 50 patients with traumatic rib fractures, participants were divided into 2 groups: a study group of 24 patients who used IS (with the flow-oriented Triflo device, which uses 3 floating balls to indicate inspiratory flows of 600, 900, and 1200 ml/s) and a control group of 26 patients who did not use IS. The study group demonstrated an improvement of 18.65% (SD 17.77%) in percentage of forced vital capacity, compared to a decrease of 4.86% (SD 10.92%) in the control group, adding evidence for the clear positive effect of IS use [7]. However, this study was limited by its small sample size, which may not have fully represented all patients with rib fracture, especially those who are not hospitalized but still experience complications. Additionally, pulmonary function was only tested within a week of injury, so the long-term effects remain unclear.

Despite its benefits, IS is often perceived as monotonous, which may reduce compliance. Gamification has emerged as a promising strategy to address this challenge by enhancing user engagement and motivation. For example, recent research on the development and testing of a mobile app–connected lung rehabilitation device (Pulmo) demonstrated that gamified breathing interventions can achieve high levels of user satisfaction and feasibility in respiratory training contexts [12]. In that study, participants rated both the game design and device responsiveness highly, with overall feasibility scores averaging 4.4 out of 5. These findings reinforce the growing evidence that interactive, game-based respiratory tools can effectively engage users in consistent lung exercise, even outside traditional clinical populations. Although the Pulmo study focused on healthy adults, its findings support the value of integrating game-based elements into respiratory training.

Similarly, the UBICU system is a gamified respiratory incentive spirometer that combines real-time biofeedback with interactive breathing games [13]. In a clinical trial, UBICU outperformed the conventional Triflo device by producing greater lung volume improvements, as measured by electrical impedance tomography, and achieving higher patient engagement and usability scores. The success of UBICU further underscores the potential of game-based platforms like OmniFlow to enhance respiratory therapy adherence and outcomes.

Evidence from other clinical populations also supports this approach. During hospitalizations for cystic fibrosis exacerbations at the University of Vermont, investigators conducted a trial involving 10 inpatients who used a digital spirometer paired with a breath biofeedback game. Patients completed at least five 15-minute sessions in which they were challenged to track a moving target using their breath. Overall, participants responded positively to the intervention, and the game was determined to be safe [14].

Patients with stroke who participated in game-based breathing exercises for 25 minutes 3 times a week over 5 weeks showed significant improvement in forced vital capacity, forced expiratory volume in 1 second, and maximum voluntary ventilation compared to those who did not. The game-based breathing exercises involved a game application installed on a laptop, paired with a headset equipped with a sensor that detects the patient’s breathing. Once activated, the game begins based on the patient’s respiratory pressure and rhythm. The application features 14 different games, each designed to guide inhalation and exhalation, while also accommodating patient preferences. Stroke patients who used game-based breathing exercises showed significant improvements in pulmonary function parameters such as forced vital capacity and forced expiratory volume in 1 second [15]. In patients with spinal cord injuries, a study developed 7 different breathing exercise devices incorporating 10 game-based exercises. Two participants engaged in a respiratory rehabilitation program twice weekly for 60-minute sessions over 8 weeks. The intervention led to improved maximum inspiratory and expiratory pressures. Participants reported that the competitive, game-like nature of the exercises enhanced their motivation, enjoyment, and adherence. Beyond respiratory benefits, the gamified exercises positively influenced psychological well-being and social engagement [16]. Furthermore, an interdisciplinary team of physical therapists, game designers, engineers, and computer scientists developed 6 prototype games to encourage patients undergoing abdominal and cardiac surgery—who are at risk for postoperative pulmonary complications—to engage in their breathing exercises. These games were found to improve the patients’ adherence to the exercises and enhance pulmonary function [8]. There have been no studies on patients with chest trauma [8].

Given these findings, our proposal introduces the OmniFlow Breathing Therapy Biofeedback System, which is designed to assist patients with breathing difficulties by offering interactive exercises through visual biofeedback in a virtual environment. This approach encourages the desired breathing response, targeting the patient’s specific impairments or conditions. The device’s airflow sensor measures the air passing through the spirette tube, allowing for the setting of inspiratory and expiratory flow and volume thresholds to guide exercise progression and optimize outcomes. Research supports the effectiveness of combining virtual reality–augmented biofeedback with traditional respiratory therapy techniques, as patients tend to perform more repetitions when motivated by positive feedback

The OmniFlow system consists of several key components, including a Microsoft Windows laptop that features on/off functionality, password protection, and a keyboard cover, while also running respiratory biofeedback software. Additionally, the system incorporates an airflow sensor for precise measurement during exercises. Disposable elements include the NDD Spirette (ndd Medical Technologies) bacterial and viral filter, an inline filter, and a barrier film to ensure hygiene and safety during use.

Games Included in the System

Overview

The OmniFlow system includes 5 interactive games, each designed to target specific breathing exercises. Each game is easy to understand, with clear instructions displayed on the OmniFlow screen, making them accessible to patients of all ages and educational backgrounds. Parameters such as inspiratory and expiratory volume and flow targets can be adjusted based on patient performance. The competitive nature of the games motivates patients to continue playing and achieve their therapeutic goals. In our study, the research team will monitor patients during their use of the OmniFlow system and discontinue the exercises if the patient ask to stop or if any of the termination criteria listed above are met.

Diamond Mine (Deep Inhalation)

This game focuses on strengthening inspiratory muscles and improving inspiratory vital capacity, which enhances diaphragmatic breathing, lung elasticity, and volume. Figure 1 illustrates the deep inhalation exercise in the Diamond Mine game. This exercise increases the muscle endurance necessary for functional activities such as self-care, respiratory-swallowing coordination, and sustained speech production. As the patient inhales a preset air volume in one breath, the game displays a vacuum collecting coins and jewels, with a large diamond awarded for reaching the target volume.

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Prehistoric Contest (Forced Expiration)

This game aims to strengthen expiratory muscles, preparing patients for functional forced expiration activities such as airway protection during swallowing, coughing, and achieving adequate intensity during phonation. The patient’s exhalation is represented as a javelin throw, with the force of the exhalation determining the distance the javelin travels. The reward increases with the target volume, culminating in a mammoth for exceeding the preset value. Figures 2 and 3 illustrate the forced expiration in the Prehistoric Contest game.

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Sail Away (Controlled Expiration)

Designed to regulate expiratory volume and flow, this game helps expel carbon dioxide, reduce dyspnea, and promote calmness. It improves diaphragm control to slow breathing, aiding sustained phonation, voice intensity, and speech intelligibility. Patients are instructed to inhale through the nose and exhale steadily through the mouth, with the exhalation moving a sailboat forward. Reaching 100% of the target volume brings the boat to a grassy island. Figure 4 illustrates the Sail Away exercise.

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Starry Road (Rhythmical Breathing)

This game trains patients in rhythmic breathing, normalizing the inhalation-exhalation ratio and addressing irregular breathing due to pain, anxiety, or stress. Proper respiratory patterns are reinforced, improving respiratory-swallow coordination, sustained phonation, voice intensity, and speech intelligibility. Patients guide a floating figure along a starry pathway by adjusting their breathing, collecting stars along the way. Figure 5 illustrates the rhythmical breathing in the Starry Road game.

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Dandelion (Active Cycle of Breathing Technique/Huff Technique)

This game teaches the active cycle of breathing, or huff, technique to mobilize and expel secretions with minimal energy expenditure. The game has 3 phases. In phase 1, breathing control, patients breathe gently to make a dandelion sway, relaxing the airways. In phase 2, thoracic expansion, patients take deep breaths and hold them to move mucus away from the lung walls, causing the dandelion to sway further. In phase 3, the huff technique, patients exhale forcefully to expel mucus, blowing dandelion seeds away as they exceed the set expiratory threshold. This technique promotes airway clearance, improving aerobic capacity and muscle endurance for functional activities and respiratory-swallow coordination. Figure 6 illustrates the Dandelion game.

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Study Goals

OmniFlow is expected to significantly improve compliance with breathing exercises in patients with thoracic trauma, as it allows them to engage in game-based exercises effortlessly, independently, and as often as desired from the comfort of their own rooms, without needing assistance from medical staff. The device is user-friendly, with simple instructions that are easy to follow. The games are safe and pose no risk of harmful effects, while offering numerous benefits, including a reduction in pulmonary complications. The competitive aspect of the games provides strong motivation for patients to continue playing, helping them achieve their respiratory therapy goals through enjoyable and effective exercises.

One key aim of this feasibility study was to better understand factors influencing patient adherence and engagement. In addition to tracking the proportion of participants who completed sessions, we systematically documented reasons for missed sessions or dropouts. These insights will help refine future study designs, including session scheduling, and support strategies to improve participation.

Limitations

We acknowledge that defining feasibility by participation in only one session is limited. Therefore, we incorporated broader process metrics—including session completion rates, interruptions, and patient interest in continuing therapy—as indicators of adherence and tolerance. While this pilot design does not include qualitative feedback such as satisfaction or perceived benefit, future trials will include structured, patient-reported usability and engagement measures to assess acceptability more comprehensively.

Another limitation of this study is the absence of predefined clinical or physiological efficacy metrics, such as spirometric measurements, serial pain scores, or respiratory rate trends. These metrics are essential for evaluating the therapeutic value of any respiratory intervention. Our current focus was to assess feasibility and safety in a complex trauma ICU environment as a foundational step. Future studies will incorporate structured efficacy end points to quantify improvements in pulmonary function, oxygenation, and symptom relief, thereby enabling a more comprehensive evaluation of clinical benefit.

Finally, the reliance on a single proprietary device (the OmniFlow Breathing Therapy Biofeedback System) may limit generalizability. Institutions without access to this technology might find replication difficult. Nevertheless, the fundamental components of the intervention—gamified breathing exercises, real-time feedback, and session-based monitoring—can be adapted to similar platforms, such as QUT Inspire (Queensland University of Technology) or other virtual spirometry tools. Future work should explore cross-platform compatibility to support broader dissemination.

Conclusion

OmniFlow offers a promising, much-needed solution for promoting adherence to breathing exercises in patients with thoracic trauma. Our 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. Although the sample size is limited to 20 participants, this aligns with established recommendations for feasibility studies and is intended to inform the design of future larger-scale trials. We acknowledge that generalizability is constrained by sample size and setting, and that feasibility thresholds—such as a ≥75% session completion rate—are preliminary benchmarks to be refined in subsequent research.