Feasibility of the Gamification of Incentive Spirometry in Trauma Patients

NCT06090279 | Withdrawn FDA Device

• 1 other identifier: IRB00097144
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Thoracic Trauma

Keywords

pulmonary therapies; incentive spirometry; pulmonary complications; pulmonary function; gamification

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

OmniFlow Breathing Therapy BioFeeback System

EXPERIMENTAL

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

Interventions

OmniFlow Breathing Therapy BioFeeback System DEVICE

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.

Also known as: healthcare gaming

OmniFlow Breathing Therapy BioFeeback System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Officials

• Aarti Sarwal, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 4, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share