Gamified Incentive Spirometry for Chest Trauma

Overseen By Areen AL-Dhoon, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Mechanical ventilation, GCS < 15, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with breathing difficulties after chest injuries using a gamified breathing system called the OmniFlow Breathing Therapy BioFeedback System. The goal is to determine if gamifying breathing exercises increases patient participation. It targets adults in the Trauma Intensive Care Unit (TICU) with rib or sternum fractures who can begin the exercises within 48 hours of admission. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the OmniFlow Breathing Therapy BioFeedback System is safe for use in patients with chest trauma?

Research has shown that the OmniFlow Breathing Therapy BioFeedback System is safe for individuals with breathing problems. The FDA has approved this system, indicating it meets safety standards for medical use. In past studies, patients used this system without major safety issues. It assists with breathing exercises by gamifying them, making it easier and more enjoyable to maintain the exercises.

Since the OmniFlow system is already approved for use, any risks are likely minimal and well understood. This makes it a promising option for those seeking to improve their breathing through engaging, game-like exercises. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OmniFlow Breathing Therapy BioFeedback System is unique because it combines FDA-approved healthcare with gaming technology to make breathing exercises more engaging for patients with chest trauma. Traditional treatments often involve standard incentive spirometry, which can be repetitive and lacks interactive features. This system stands out by offering biofeedback, which gives real-time responses to patients, making it easier for them to track their progress and stay motivated. Researchers are excited about its potential to improve patient adherence to pulmonary rehab, possibly leading to better outcomes and quicker recovery times.

What evidence suggests that the OmniFlow Breathing Therapy BioFeedback System is effective for chest trauma?

Research shows that the OmniFlow Breathing Therapy BioFeedback System, used by participants in this trial, can improve lung function. Studies have found that it greatly increases adherence to breathing exercises, especially in patients with chest injuries. By turning breathing exercises into a game, this system keeps patients engaged. Early results indicate that it strengthens breathing muscles and enhances overall lung health compared to traditional methods. Overall, the OmniFlow system offers a promising approach to making respiratory therapy more interactive and enjoyable. ^{1 2 4 5 6}

Who Is on the Research Team?

Aarti Sarwal, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults (18+) in the Trauma Intensive Care Unit with rib fractures or similar chest injuries. They must be able to give consent and start gamified breathing therapy within 48 hours of admission.

Inclusion Criteria

I am an adult with broken ribs or a broken breastbone.

Patients will be included if informed consent can be obtained from patient themselves and first session of incentive spirometry gamification can be performed within 48 hours of Trauma Intensive Care Unit (TICU) admission

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the OmniFlow Breathing Therapy BioFeedback System for pulmonary rehabilitation

up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OmniFlow Breathing Therapy BioFeeback System

Trial Overview The study tests a biofeedback system called OmniFlow, which turns breathing exercises into a game to see if it helps patients stick with their therapy after chest trauma.

How Is the Trial Designed?

Group I: OmniFlow Breathing Therapy BioFeeback System Experimental Treatment 1 Intervention

This system is a FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. acplus.com acplus.com/technology/omniflow/

OmniFlow® | ACPlus OmniFlow® exercise parameters are easily customizable and provide valuable inhalation and exhalation data to the clinician. This helps to more effectively ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357117/

Gamification of Incentive Spirometry in Trauma Patients OmniFlow is expected to significantly improve compliance with breathing exercises in patients with thoracic trauma, as it allows them to engage ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10674163/

Biofeedback Respiratory Rehabilitation Training System ... The results show that this system has significantly improved the patient's lung function. Compared with traditional training methods, the ...

4. acplus.com acplus.com/blog/omniflow/breathing-exercise-improves-adls-core-stability-and-pain/

Breathing Exercise Improves ADLs, Core Stability, and Pain OmniFlow® Breathing Therapy Biofeedback System incorporates inspiratory and expiratory breathing exercise to improve respiratory muscle ...

5. researchgate.net researchgate.net/publication/394220292_Gamification_of_Incentive_Spirometry_in_Trauma_Patients_Protocol_for_a_Prospective_Observational_Feasibility_Study

Gamification of Incentive Spirometry in Trauma Patients ... OmniFlow Breathing Therapy BioFeedback System in trauma patients. While preliminary observations related to potential clinical efficacy (eg ...

6. withpower.com withpower.com/trial/phase-wounds-and-injuries-11-2023-844ff

Gamified Incentive Spirometry for Chest Trauma Trial Overview The study tests a biofeedback system called OmniFlow, which turns breathing exercises into a game to see if it helps patients stick with their ...