## Protocol Section
### Identification Module
**NCT ID:** NCT06090279

**Brief Title:** Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

**Official Title:** Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

#### Organization Study ID Info
**ID:** IRB00097144
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-13
**Study First Submit QC Date:** 2023-10-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Thoracic Trauma

**Keywords:**

- pulmonary therapies

- incentive spirometry

- pulmonary complications

- pulmonary function

- gamification

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** a minimum of 3 rounds of game usage in the Trauma Intensive Care Unit (TICU). Each patient will receive at least 2 sessions per day.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: OmniFlow Breathing Therapy BioFeeback System

**Label:** OmniFlow Breathing Therapy BioFeeback System

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- OmniFlow Breathing Therapy BioFeeback System

**Description:** 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.

**Name:** OmniFlow Breathing Therapy BioFeeback System

**Other Names:**

- healthcare gaming

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number screened and eligible compared to patient that consented to project

**Measure:** Number screened and eligible compared to patient that consented to project

**Time Frame:** up to 6 months

**Description:** Number of sessions attempted, completed and aborted including the time spent in successful intervention

**Measure:** Number of sessions attempted, completed and aborted including the time spent in successful intervention

**Time Frame:** up to 6 months

**Description:** 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

**Measure:** Reasons for aborting a session related to patient factors, staffing factors, technology factors

**Time Frame:** up to 6 months

**Description:** Number of days spent in Intensive Care Unit (ICU)

**Measure:** Number of days spent in Intensive Care Unit (ICU)

**Time Frame:** up to 6 months

**Description:** Number of Subjects readmitted to the ICU for pulmonary complications

**Measure:** Number of Subjects readmitted to the ICU for pulmonary complications

**Time Frame:** up to 6 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aaldhoon@wakehealth.edu

**Name:** Areen AL-Dhoon, MBBS

**Phone:** 336-405-0740

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winston-Salem

**Contacts:**

***Contact 1:***

- **Email:** aaldhoon@wakehealth.edu

- **Name:** Areen AL-Dhoon, MBBS

- **Phone:** 336-405-0740

- **Role:** CONTACT

***Contact 2:***

- **Email:** adgrimes@wakehealth.edu

- **Name:** Arthur Grimes, MD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Aarti Sarwal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Aarti Sarwal, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Trauma

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-24
