Clinical trial NCT06090279: Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
Official title: Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thoracic Trauma
Keywords: pulmonary therapies
incentive spirometry
pulmonary complications
pulmonary function
gamification
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number screened and eligible compared to patient that consented to project
timeFrame: up to 6 months
measure: Number of sessions attempted, completed and aborted including the time spent in successful intervention
timeFrame: up to 6 months
measure: Reasons for aborting a session related to patient factors, staffing factors, technology factors
timeFrame: up to 6 months
measure: Number of days spent in Intensive Care Unit (ICU)
timeFrame: up to 6 months
measure: Number of Subjects readmitted to the ICU for pulmonary complications
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Aarti Sarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: