Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

Thoracic Trauma Clinical Trial

Official title:

Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090279
• Other study ID #: IRB00097144
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Areen AL-Dhoon, MBBS
• Phone: 336-405-0740
• Email: aaldhoon[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of days spent in Intensive Care Unit (ICU)	Number of days spent in Intensive Care Unit (ICU)	up to 6 months
Primary	Number of Subjects readmitted to the ICU for pulmonary complications	Number of Subjects readmitted to the ICU for pulmonary complications	up to 6 months