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Behavioural Intervention

ZEPHYRx Respiratory Therapy (RT) System for Thoracic Surgery

N/A

Waitlist Available

Led By Michal Lada, MD

Research Sponsored by My Music Machines Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial is comparing the ZEPHYRx Respiratory Therapy system to the standard of care incentive spirometer, to see which is better in terms of usability, simplicity, and effectiveness.

Eligible Conditions

Thoracic Surgery
Respiratory Therapy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to prescribed spirometry routine

Hospital Readmission

Lung Volume

Secondary outcome measures

Atelectasis

Device Usability

Length of Stay

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active Study GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 Intervention

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.

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Who is running the clinical trial?

My Music Machines Inc.Lead Sponsor

3 Previous Clinical Trials

102 Total Patients Enrolled

University of RochesterOTHER

837 Previous Clinical Trials

518,017 Total Patients Enrolled

Michal Lada, MDPrincipal InvestigatorUniversity of Rochester

Media Library

ZEPHYRx Respiratory Therapy (RT) System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04429009 — N/A

Thoracic Surgery Research Study Groups: Active Study Group, Control Group

Thoracic Surgery Clinical Trial 2023: ZEPHYRx Respiratory Therapy (RT) System Highlights & Side Effects. Trial Name: NCT04429009 — N/A

ZEPHYRx Respiratory Therapy (RT) System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04429009 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots remaining in the clinical trial?

"From clinicaltrials.gov, it appears that this medical trial is not being conducted at the present time. This study's first posting was on September 1st 2021 and its last update occurred on August 24th 2022. Despite the closure of this investigation, there are 20 other trials actively searching for participants currently."

Answered by AI

Who meets the criteria for enrolling in this medical study?

"This trial is looking to enroll approximately 100 individuals between the ages of 18 and 75 who have undergone thoracic surgery."

Answered by AI

Is this research study open to participants over the age of eighty-five?

"The conditions to join this medical trial mandate that potential participants are aged 18 or over and no older than 75."

Answered by AI

What is the desired outcome of this research endeavor?

"The objective of this time-limited clinical trial is to reduce the rate of Hospital Readmission. Secondary outcomes include a 5 point assessment of Atelectasis, Length of Stay post operatively, and Pain Scale pre and post exercises which utilize a 0-10 Wong-Baker FACES pain scale with facial expressions indicating pain severity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04429009.