Thoracic TraumaNCT06090279
Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
A study testing OmniFlow Breathing Therapy BioFeeback System in people with Thoracic Trauma, run by Wake Forest University Health Sciences.
Trial summary
Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Trauma
- What is being tested?
- OmniFlow Breathing Therapy BioFeeback System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.
Read the 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
- Thoracic Trauma
- Being tested
- OmniFlow Breathing Therapy BioFeeback System
- Keywords
- pulmonary therapies, incentive spirometry, pulmonary complications, pulmonary function, gamification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniFlow Breathing Therapy BioFeeback SystemDevice
Also called healthcare gaming
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OmniFlow Breathing Therapy BioFeeback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number screened and eligible compared to patient that consented to project
Number screened and eligible compared to patient that consented to project
Measured: 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
Measured: 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
Measured: up to 6 months
Number of days spent in Intensive Care Unit (ICU)
Number of days spent in Intensive Care Unit (ICU)
Measured: up to 6 months
Number of Subjects readmitted to the ICU for pulmonary complications
Number of Subjects readmitted to the ICU for pulmonary complications
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: significant delays in acquiring the equipment that was supposed to be loaned for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic TraumaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aarti Sarwal, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090279
- Sponsor's protocol ID
- IRB00097144
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
- ClinicalTrials.gov ID
- NCT06090279
- Acronym / sponsor ID
- IRB00097144
- Conditions
- Thoracic Trauma
- Keywords
- pulmonary therapies, incentive spirometry, pulmonary complications, pulmonary function, gamification
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: significant delays in acquiring the equipment that was supposed to be loaned for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| OmniFlow Breathing Therapy BioFeeback System | Experimental | Device: OmniFlow Breathing Therapy BioFeeback SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniFlow Breathing Therapy BioFeeback SystemAlso: healthcare gamingFDA 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. | Device | OmniFlow Breathing Therapy BioFeeback System |
Primary outcome
Number screened and eligible compared to patient that consented to project
Time frame: up to 6 months
Number screened and eligible compared to patient that consented to project
Number of sessions attempted, completed and aborted including the time spent in successful intervention
Time frame: up to 6 months
Number of sessions attempted, completed and aborted including the time spent in successful intervention
Reasons for aborting a session related to patient factors, staffing factors, technology factors
Time frame: up to 6 months
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
Number of days spent in Intensive Care Unit (ICU)
Time frame: up to 6 months
Number of days spent in Intensive Care Unit (ICU)
Number of Subjects readmitted to the ICU for pulmonary complications
Time frame: up to 6 months
Number of Subjects readmitted to the ICU for pulmonary complications
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarti Sarwal, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing OmniFlow Breathing Therapy BioFeeback System in people with Thoracic Trauma, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number screened and eligible compared to patient that consented to project (time frame: up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.