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.

A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry

Thoracic Surgery

Respiratory Therapy

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.

ZEPHYRx Respiratory Therapy (RT) System

Standard Incentive Spirometer

Number of deep breaths taken per day with the prescribed device

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 within 30 days of discharge

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)

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.

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)

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:
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.
A Samsung 10-inch tablet provided by Pad-in-Motion Inc. that will be connected to the hospital GuestWiFi network.
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.

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.

A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status