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

NCT04429009 | Unknown FDA Device

• 1 other identifier: ZEPHYRx Rochester
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Surgery; Respiratory Therapy

Outcome Measures

Primary Outcomes (3)

• Adherence to prescribed spirometry routine

  Number of deep breaths taken per day with the prescribed device

  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

  From extubation post-surgery to hospital discharge (estimated average of 2-4 days)

• Hospital Readmission

  Hospital Readmission within 30 days of discharge

  30 days post discharge

Secondary Outcomes (4)

• Atelectasis

  Evaluated for any required x-ray procedures during length of post-operated hospital stay (estimated 2-4 days per patient)

• Device Usability

  At time of discharge (estimated to be 2-4 days post surgery extubation)

• Pain Scale pre and post exercises

  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

  From extubation post-surgery to hospital discharge (estimated average of 2-4 days)

Study Arms (2)

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.

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.

Device: Standard Incentive Spirometer

Interventions

ZEPHYRx Respiratory Therapy (RT) System DEVICE

A breath controlled video game system for respiratory therapy

Active Study Group

Standard Incentive Spirometer DEVICE

A simple (not digital) plastic device that contains a piston that rises inside the device and measures the volume of your breath

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients ages 18+ undergoing thoracic lobectomy surgery or wedge resection for tumor/nodule excisionat the University of Rochester Medical Center.

You may not qualify if:

• 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)

Sponsors & Collaborators

• My Music Machines Inc.: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Michal Lada, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 11, 2020
• Study Start: September 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)