Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04429009 |
| Other study ID # |
ZEPHYRx Rochester |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
My Music Machines Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
