Back to resultsFeasibility of the Gamification of Incentive Spirometry in Trauma Patients
Primary Purpose
Thoracic Trauma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OmniFlow Breathing Therapy BioFeeback System
Sponsored by
About this trial
This is an interventional supportive care trial for Thoracic Trauma focused on measuring pulmonary therapies, incentive spirometry, pulmonary complications, pulmonary function, gamification
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
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OmniFlow Breathing Therapy BioFeeback System
Arm 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.
Outcomes
Primary Outcome Measures
Number screened and eligible compared to patient that consented to project
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
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
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)
Number of days spent in Intensive Care Unit (ICU)
Number of Subjects readmitted to the ICU for pulmonary complications
Number of Subjects readmitted to the ICU for pulmonary complications
Secondary Outcome Measures
Full Information
NCT ID
NCT06090279
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Trauma
Keywords
pulmonary therapies, incentive spirometry, pulmonary complications, pulmonary function, gamification
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OmniFlow Breathing Therapy BioFeeback System
Arm Type
Experimental
Arm 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 Type
Device
Intervention Name(s)
OmniFlow Breathing Therapy BioFeeback System
Other Intervention Name(s)
healthcare gaming
Intervention 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.
Primary Outcome Measure Information:
Title
Number screened and eligible compared to patient that consented to project
Description
Number screened and eligible compared to patient that consented to project
Time Frame
up to 6 months
Title
Number of sessions attempted, completed and aborted including the time spent in successful intervention
Description
Number of sessions attempted, completed and aborted including the time spent in successful intervention
Time Frame
up to 6 months
Title
Reasons for aborting a session related to patient factors, staffing factors, technology factors
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
Time Frame
up to 6 months
Title
Number of days spent in Intensive Care Unit (ICU)
Description
Number of days spent in Intensive Care Unit (ICU)
Time Frame
up to 6 months
Title
Number of Subjects readmitted to the ICU for pulmonary complications
Description
Number of Subjects readmitted to the ICU for pulmonary complications
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Areen AL-Dhoon, MBBS
Phone
336-405-0740
Email
aaldhoon@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aarti Sarwal, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areen AL-Dhoon, MBBS
Phone
336-405-0740
Email
aaldhoon@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Arthur Grimes, MD
Email
adgrimes@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Aarti Sarwal, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
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