Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
NCT ID: NCT06090279
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-01-31
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patients (≥ 18 years of age) in the TICU with rib fractures or flail segment or a sternal fracture
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Aarti Sarwal, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Other Identifiers
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IRB00097144
Identifier Type: -
Identifier Source: org_study_id
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