Thoracic SurgeryNCT04429009
A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry
A study testing ZEPHYRx Respiratory Therapy (RT) System and Standard Incentive Spirometer in people with Thoracic Surgery and Respiratory Therapy, run by My Music Machines Inc. at 1 site in United States.
Trial summary
The primary aim of this randomized control trial is to analyze by direct comparison the ZEPHYRx Respiratory Therapy (RT) system and the FDA approved standard of care (SOC) incentive spirometer (IS), used for FDA approved indications at the University of Rochester Medical Center (URMC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery, Respiratory Therapy
- What is being tested?
- ZEPHYRx Respiratory Therapy (RT) System and Standard Incentive Spirometer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Sep 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients ages 18+ undergoing thoracic lobectomy surgery or wedge resection for tumor/nodule excisionat the University of Rochester Medical Center.
Who cannot join
- Patients under the age of 18
- Patients with diminished physical or mental capacity that make them incapable of operating a standard spirometer device
- Patients with visual or hearing impairments that make it difficult to understand verbal or written instructions
- Patients who are not able to read the language the ZEPHYRx software is available in (currently available only in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The primary aim of this randomized control trial is to analyze by direct comparison the ZEPHYRx Respiratory Therapy (RT) system and the FDA approved standard of care (SOC) incentive spirometer (IS), used for FDA approved indications at the University of Rochester Medical Center (URMC). This comparison will determine subject preferences in terms of usability and simplicity of each, as well as subject engagement and adherence to the prescribed respiratory therapy routine. Additionally, the study will analyze the effectiveness of the gamified spirometry with regards to spirometry volumes, frequency of usage, and pulmonary complications 30 days post discharge.
Read the detailed description
Lobectomy and wedge resection patients at University of Rochester Medical Center meeting the eligibility criteria will be screened and consented by members of the research team prior to surgery at their pre-operative clinic visit. Once a subject meets the inclusion criteria for this study, the subject will be randomly assigned to one of the two arms of this study by a flip of a coin. To ensure that we meet the predicted 50 subjects in each arm of the study, every second subject enrolled will be assigned to the opposite arm of the previously assigned subject.
Subjects enrolled in the study arm:
Following surgery or extubation, and once no longer under the influence of anesthesia, the patient enrolled into the study arm will be provided with a ZEPHYRx incentive spirometer device connected to an Amazon Kindle Fire HD Tablet. A respiratory therapist, nurse, doctor, or research team member will teach the subject how to use the device and the tablet, and walk them through the first series of breaths. A built-in bell reminder in the device will ring once every hour between the hours of 8:00 a.m. and 8:00 p.m. to remind patients to use the device, this feature is part of the research and a feature programmed into the device. Additionally, subjects will answer questions on their tablet about pain level on a scale of 0-10 before and after each round of game play. At discharge, the subjects in the study arm will return their assigned tablet and will be issued a standard incentive spirometer to continue respiratory therapy at home, per standard of care. Subjects in the study arm will not be held responsible for lost, stolen or damaged tablets or incentive spirometers. The subject in the study arm may choose to keep or discard the ZEPHYRx incentive spirometer device. The device will record subject usage, including number of breaths, number of sessions, total time the device was in use, inspiratory volumes, and pain level (0-10) before and after each round of game play.
Subjects enrolled in the control arm:
Following surgery or extubation, and once no longer under the influence of anesthesia, the patient enrolled in the control arm will meet with an RT, nurse, doctor, or research team member to receive an FDA approved incentive spirometry device and appropriate training thus initiating the study. Routine respiratory care involves the use of a standard incentive spirometer that is not a digital device and does not include any built-in reminder. As per routine care, the nurse or respiratory therapist will remind the subjects in both arms of the study to perform their respiratory therapy of at least 10 breaths per hour. In order to obtain data comparable to what the ZEPHYRx respiratory therapy system will collect, similar data will be collected from subjects in the control arm on a data sheet by an RT, nurse, doctor, or research team member 3 times a day until the subject is discharged. The only questionnaire will be the standard of care pain scale questions which the subjects in the control arm will have to complete in written form. Upon discharge, subjects in the control arm of the study will be allowed to keep their standard of care incentive spirometer in order to continue respiratory therapy at home, per standard of care. Subjects in the control arm will not be held responsible for lost, stolen or damaged incentive spirometers.
On a daily basis, a member of the research team will check that the device(s) is/are working correctly and will answer any questions the subject may have regarding the study or device.
- Conditions
- Thoracic Surgery, Respiratory Therapy
- Being tested
- ZEPHYRx Respiratory Therapy (RT) System, Standard Incentive Spirometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEPHYRx Respiratory Therapy (RT) SystemDevice
A breath controlled video game system for respiratory therapy
Standard Incentive SpirometerDevice
A simple (not digital) plastic device that contains a piston that rises inside the device and measures the volume of your breath
| Study group | Role | What they receive |
|---|---|---|
| Active Study Group | Experimental | Participants in this group will be prescribed to use the ZEPHYRx RT device for incentive spectrometer once every hour during waking hours to perform a series of 10 deep breaths. The novel ZEPHYRx RT system consists three components:
1. The Spirobank Smart Spirometer, which is a non-significant risk, FDA-cleared diagnostic spirometer made by Medical International Research (MIR) that connects via bluetooth to an Android tablet.
2. A Samsung 10-inch tablet provided by Pad-in-Motion Inc. that will be connected to the hospital GuestWiFi network.
3. The ZEPHYRx Respiratory Therapy video game application installed on the tablet. This application consists of seven games that have been created to combine traditional IS techniques with playing a breath controlled video game. The application will record data while playing the video games including date/time of use, game played, inhalation duration, and inhalation volume. Receives: Device: ZEPHYRx Respiratory Therapy (RT) System |
| Control Group | Active comparator | Participants in this group will be prescribed to routine respiratory care, Routine respiratory care involves the use of a standard incentive spirometer that is not a digital device and does not include any built-in reminder. As per routine care, the nurse or respiratory therapist will remind the subjects to perform a series of at least 10 deep breaths every hour. Receives: Device: Standard Incentive Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to prescribed spirometry routine
Number of deep breaths taken per day with the prescribed device
Measured: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Lung Volume
Average daily inspiratory volume of the breaths taken with the prescribed device. Recorded 3 times per day by nurse or RT for the control group, and recorded at each use by the device for the active study group
Measured: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Hospital Readmission
Hospital Readmission within 30 days of discharge
Measured: 30 days post discharge
Secondary outcomes (4)
Atelectasis
Degree of Atelectasis assessed from chest radiography on a 5 point scale, where high scores correspond to more severe disease (1. no apparent disease, 2. subsegmental atelectasis, 3. segmental atelectasis, 4. lobar atelectasis, or 5. pneumonia)
Measured: Evaluated for any required x-ray procedures during length of post-operated hospital stay (estimated 2-4 days per patient)
Device Usability
A brief survey including likert scale questions on usability, and open ended feedback. Questions will be asked on a 5 point scale (1. strongly agree, 2. somewhat agree, 3. Neutral, 4. somewhat disagree, strongly disagree), with lower scores corresponding to better acceptance of the device.
Measured: At time of discharge (estimated to be 2-4 days post surgery extubation)
Pain Scale pre and post exercises
A measure of pain on the 0-10 Wong-Baker FACES pain scale that uses images of faces to determine pain level. 0 = no hurt (happy face), 10 = worst hurt (crying face)
Measured: Recorded before and after each session with the device for the treatment group, and by a nurse via paper survey 3 times per day for the control group during the length of hospital stay (estimated 2-4 days per patient)
Length of Stay
Post Operative Hospital Length of Stay
Measured: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Sep 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All lobectomy and wedge resection patients meeting the inclusion criteria will be recruited (from the start of the study date until recruitment goal it reached) and consenting participants will be randomized to a study arm or a control arm. Each arm will consist of 50 subjects.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- My Music Machines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Michal Lada, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429009
- Sponsor's protocol ID
- ZEPHYRx Rochester
- Status last verified
- Aug 2022
- First submitted
- 12 May 2020
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry
- ClinicalTrials.gov ID
- NCT04429009
- Acronym / sponsor ID
- ZEPHYRx Rochester
- Conditions
- Thoracic Surgery, Respiratory Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- My Music Machines Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 11 Jun 2020 (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.
The primary aim of this randomized control trial is to analyze by direct comparison the ZEPHYRx Respiratory Therapy (RT) system and the FDA approved standard of care (SOC) incentive spirometer (IS), used for FDA approved indications at the University of Rochester Medical Center (URMC). This comparison will determine subject preferences in terms of usability and simplicity of each, as well as subject engagement and adherence to the prescribed respiratory therapy routine. Additionally, the study will analyze the effectiveness of the gamified spirometry with regards to spirometry volumes, frequency of usage, and pulmonary complications 30 days post discharge.
Detailed description
Lobectomy and wedge resection patients at University of Rochester Medical Center meeting the eligibility criteria will be screened and consented by members of the research team prior to surgery at their pre-operative clinic visit. Once a subject meets the inclusion criteria for this study, the subject will be randomly assigned to one of the two arms of this study by a flip of a coin. To ensure that we meet the predicted 50 subjects in each arm of the study, every second subject enrolled will be assigned to the opposite arm of the previously assigned subject.
Subjects enrolled in the study arm:
Following surgery or extubation, and once no longer under the influence of anesthesia, the patient enrolled into the study arm will be provided with a ZEPHYRx incentive spirometer device connected to an Amazon Kindle Fire HD Tablet. A respiratory therapist, nurse, doctor, or research team member will teach the subject how to use the device and the tablet, and walk them through the first series of breaths. A built-in bell reminder in the device will ring once every hour between the hours of 8:00 a.m. and 8:00 p.m. to remind patients to use the device, this feature is part of the research and a feature programmed into the device. Additionally, subjects will answer questions on their tablet about pain level on a scale of 0-10 before and after each round of game play. At discharge, the subjects in the study arm will return their assigned tablet and will be issued a standard incentive spirometer to continue respiratory therapy at home, per standard of care. Subjects in the study arm will not be held responsible for lost, stolen or damaged tablets or incentive spirometers. The subject in the study arm may choose to keep or discard the ZEPHYRx incentive spirometer device. The device will record subject usage, including number of breaths, number of sessions, total time the device was in use, inspiratory volumes, and pain level (0-10) before and after each round of game play.
Subjects enrolled in the control arm:
Following surgery or extubation, and once no longer under the influence of anesthesia, the patient enrolled in the control arm will meet with an RT, nurse, doctor, or research team member to receive an FDA approved incentive spirometry device and appropriate training thus initiating the study. Routine respiratory care involves the use of a standard incentive spirometer that is not a digital device and does not include any built-in reminder. As per routine care, the nurse or respiratory therapist will remind the subjects in both arms of the study to perform their respiratory therapy of at least 10 breaths per hour. In order to obtain data comparable to what the ZEPHYRx respiratory therapy system will collect, similar data will be collected from subjects in the control arm on a data sheet by an RT, nurse, doctor, or research team member 3 times a day until the subject is discharged. The only questionnaire will be the standard of care pain scale questions which the subjects in the control arm will have to complete in written form. Upon discharge, subjects in the control arm of the study will be allowed to keep their standard of care incentive spirometer in order to continue respiratory therapy at home, per standard of care. Subjects in the control arm will not be held responsible for lost, stolen or damaged incentive spirometers.
On a daily basis, a member of the research team will check that the device(s) is/are working correctly and will answer any questions the subject may have regarding the study or device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All lobectomy and wedge resection patients meeting the inclusion criteria will be recruited (from the start of the study date until recruitment goal it reached) and consenting participants will be randomized to a study arm or a control arm. Each arm will consist of 50 subjects.
| Arm | Type | Receives |
|---|---|---|
| Active Study Group | Experimental | Device: ZEPHYRx Respiratory Therapy (RT) SystemParticipants in this group will be prescribed to use the ZEPHYRx RT device for incentive spectrometer once every hour during waking hours to perform a series of 10 deep breaths. The novel ZEPHYRx RT system consists three components: 1. The Spirobank Smart Spirometer, which is a non-significant risk, FDA-cleared diagnostic spirometer made by Medical International Research (MIR) that connects via bluetooth to an Android tablet. 2. A Samsung 10-inch tablet provided by Pad-in-Motion Inc. that will be connected to the hospital GuestWiFi network. 3. The ZEPHYRx Respiratory Therapy video game application installed on the tablet. This application consists of seven games that have been created to combine traditional IS techniques with playing a breath controlled video game. The application will record data while playing the video games including date/time of use, game played, inhalation duration, and inhalation volume. |
| Control Group | Active comparator | Device: Standard Incentive SpirometerParticipants in this group will be prescribed to routine respiratory care, Routine respiratory care involves the use of a standard incentive spirometer that is not a digital device and does not include any built-in reminder. As per routine care, the nurse or respiratory therapist will remind the subjects to perform a series of at least 10 deep breaths every hour. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients ages 18+ undergoing thoracic lobectomy surgery or wedge resection for tumor/nodule excisionat the University of Rochester Medical Center.
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients with diminished physical or mental capacity that make them incapable of operating a standard spirometer device
- Patients with visual or hearing impairments that make it difficult to understand verbal or written instructions
- Patients who are not able to read the language the ZEPHYRx software is available in (currently available only in English)
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 |
|---|---|---|
| ZEPHYRx Respiratory Therapy (RT) SystemA breath controlled video game system for respiratory therapy | Device | Active Study Group |
| Standard Incentive SpirometerA simple (not digital) plastic device that contains a piston that rises inside the device and measures the volume of your breath | Device | Control Group |
Primary outcome
Adherence to prescribed spirometry routine
Time frame: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Number of deep breaths taken per day with the prescribed device
Lung Volume
Time frame: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Average daily inspiratory volume of the breaths taken with the prescribed device. Recorded 3 times per day by nurse or RT for the control group, and recorded at each use by the device for the active study group
Hospital Readmission
Time frame: 30 days post discharge
Hospital Readmission within 30 days of discharge
4 secondary outcomes
Atelectasis
Time frame: Evaluated for any required x-ray procedures during length of post-operated hospital stay (estimated 2-4 days per patient)
Device Usability
Time frame: At time of discharge (estimated to be 2-4 days post surgery extubation)
Pain Scale pre and post exercises
Time frame: Recorded before and after each session with the device for the treatment group, and by a nurse via paper survey 3 times per day for the control group during the length of hospital stay (estimated 2-4 days per patient)
Length of Stay
Time frame: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- 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.
Michal Lada, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZEPHYRx Respiratory Therapy (RT) System and Standard Incentive Spirometer in people with Thoracic Surgery and Respiratory Therapy, run by My Music Machines Inc. at 1 site in United States.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Adherence to prescribed spirometry routine (time frame: From extubation post-surgery to hospital discharge (estimated average of 2-4 days)). The study lists 3 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 25 Aug 2022.