Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.

Study Overview

• Status: Withdrawn
• Conditions: Thoracic Trauma
• Intervention / Treatment: Device: OmniFlow Breathing Therapy BioFeeback System

Detailed Description

Recently, there has been much interest in the gamification of healthcare, such as virtual incentive spirometry gaming. Several studies have examined the addition of gamification e.g. virtual incentive spirometry devices. There is a paucity of data regarding the gamification of incentive spirometry, and there is no data involving trauma patients. Previous studies have enrolled either healthy volunteers or patients with specific lung pathology. This study to assess the safety, feasibility and efficacy of respiratory interventions in chest trauma patients using a therapeutic gamification platform.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Adult patients (≥ 18 years of age) in the TICU with rib fractures or flail segment or a sternal fracture

Exclusion Criteria:

• Trauma patients in the TICU who are mechanically ventilated or requiring bilevel positive airway pressure (BiPAP)
• Glasgow Coma Scale (GCS) < 15, at the time of enrollment
• Facial fractures precluding the use of incentive spirometry
• Any organ injury that precludes use of respiratory therapies in the clinical judgement of the clinical team
• Patients who are expected to be transferred out of the TICU or discharged from the TICU in the next 24 hours based on treating physicians judgment
• Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physician's judgment will not be included
• Patients unable to consent for themselves
• Patients unable to use the mouthpiece of the Omniflow system, and those who have visual or hearing impairments that could limit their ability to evaluate the games

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OmniFlow Breathing Therapy BioFeeback System; 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.	Device: OmniFlow Breathing Therapy BioFeeback System; 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. Each game usage itself is expected to last 15-20 minutes.; Other Names: healthcare gaming

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number screened and eligible compared to patient that consented to project	Number screened and eligible compared to patient that consented to project	up to 6 months
Number of sessions attempted, completed and aborted including the time spent in successful intervention	Number of sessions attempted, completed and aborted including the time spent in successful intervention	up to 6 months
Reasons for aborting a session related to patient factors, staffing factors, technology factors	Enter the results according to the reason The Session will be terminated if one or more of the following occurs: Sustained Pain Score >8/10; Increase in oxygen requirements by more than 2L/min or hypoxia to less than 92% during the intervention or need for escalation of an oxygen supplementation device; Sustained Heart Rate >110 beats per minute, new cardiac arrhythmia or respiratory rate >30 per minute; Cyanosis, pallor, or new onset confusion; Refusal to continue by choice, reduced engagement in game, adverse symptoms related to dyspnea, pain or discomfort related to the intervention; These safety measures are vital sign derangements or signs/symptoms that predict threat to the patient's health; Sessions unable to be performed after enrollment due to lack of personnel; Failure of intervention device to work, failure of accompanying gamification platform to work	up to 6 months
Number of days spent in Intensive Care Unit (ICU)	Number of days spent in Intensive Care Unit (ICU)	up to 6 months
Number of Subjects readmitted to the ICU for pulmonary complications	Number of Subjects readmitted to the ICU for pulmonary complications	up to 6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Aarti Sarwal, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pulmonary function; gamification; pulmonary complications; incentive spirometry; pulmonary therapies
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: IRB00097144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No