The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3

NCT ID: NCT03547349

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-03-10

Brief Summary

The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device (see appendix A for device details) combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance.

This study addresses postoperative pulmonary atelectasis that results from diaphragm dysfunction and pain following upper abdominal surgery. This issue is a major cause of morbidity in these patients (Ford et al 1983). Incentive spirometry is used in this setting, but there is conflicting data regarding its effectiveness (Rupp et al 2013). Study 3 will focus on the questions regarding the influence of education and a novel use of a gaming device on prevention of atelectasis. Study 3 will include 3 subgroups of subjects. The first subject group will be enrolled in a nonintrusive observation only studies. Group 1 will explore the effect of technology via a tablet device on standard spirometry usage. Group 2 will look at the combined effect of technology via the tablet device and intensive education on compliance and reduction of post-surgical atelectasis. Finally, Group 3 will explore the effect of gaming technology with intensive educational reinforcement on compliance and reduction of post-surgical atelectasis.

Detailed Description

Testing Plan: Study participants will be enrolled sequentially in one of three study groups:

• Group 1 - the first 25 patients will be consented to participate by a member of the research team. These study patients will receive a study information/authorization sheet about the study prior to surgery during their pre-operative clinic visit. This subgroup will be provided postoperatively with an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer. Subjects in this group will receive current standard of care with routine surgical and RN encouragement to use the spirometer. The tablet will monitor and record spirometer device utilization. Demographic data (age ( or >89), gender, ethnicity) and body mass index (BMI) will be collected. No patient identifiers will be collected. At 72 hours or at discharge, the devices will be exchanged for standard issue incentive spirometer. Research staff will extract the demographic data described above as well as BMI.

Randomized Study Subgroups:

• Groups 2 and 3 are active study groups. -Patients will be randomized via a random number generator post-operatively to group 2 or 3, stratified by surgery type (laparoscopic or open) . Each subgroup will include a total of 72 randomized participants

Group 2 : These study patients will be consented by members of the research team prior to surgery at their pre-operative clinic visit. The patient will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer, and will set a spirometry goal while collecting usage and pulmonary function data. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge. This education will be done to reinforce the standard instruction provided by the hospital staff.

Research staff will collect data on pain, utilization of incentive spirometry, and room air oximetry. The oximetry measurements will be collected after patients have been off of oxygen for between 3.5 to 4 minutes. For patients requiring high levels of supplemental oxygen (pulse oximetry measurement (<90%), oxygen will not be removed for pulse oximetry measurements. The additional education and oximetry measure will be collected by a respiratory therapist three times a day at the preferred times of 0600, 1200 and 1800 post operatively. Patients will remain on study for 72 hours post-surgery, return to the OR, SICU admission or medical prescription of directed chest physiotherapy.

A Chest x-ray will be obtained at 48 hours post-surgery. Demographic data (age ( or >89), gender, ethnicity), pulmonary function data and body mass index (BMI) will be collected. No patient identifiers will be collected. At 72 hours or at discharge, the devices will be exchanged for standard issue incentive spirometer.

Group 3: These study patients will be consented by a member of the research team prior to surgery at their pre-operative clinic visit. The patients will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with both intensive education reinforcement and a spirometry tablet device that also includes multiple gaming programs. The games are meant to encourage incentive spirometry and are programmed to progress in accordance with the patient's personal increasing capacity.

This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer, and will set a spirometry goal while collecting usage and pulmonary function data. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge. This education will be done to reinforce the standard instruction provided by the hospital staff.

Research staff will collect data on pain, utilization of incentive spirometry, and room air oximetry. The oximetry measurements will be collected after patients have been off of oxygen for between 3.5 to 4 minutes. For patients requiring high levels of supplemental oxygen (pulse oximetry measurement <90%),oxygen will not be removed for pulse oximetry measurements. The additional education and oximetry measure will be collected by a respiratory therapist three times a day at the preferred times of 0600, 1200 and 1800 post operatively. Patients will remain on study for 72 hours post-surgery, return to the OR, SICU admission or medical prescription of directed chest physiotherapy.

A Chest x-ray will be obtained at 48 hours post-surgery. Demographic data (age ( or >89), gender, ethnicity), pulmonary function data and body mass index (BMI) will be collected. No patient identifiers will be collected. At 72 hours or at discharge, the devices will be exchanged for standard issue incentive spirometer.

Conditions

Atelectases, Postoperative Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1

These study patients will receive a study information/authorization sheet about the study prior to surgery during their pre-operative clinic visit. This subgroup will be provided postoperatively with a digital incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer. Subjects in this group will receive current standard of care with routine surgical and RN encouragement to use the spirometer. The tablet will monitor and record spirometer device utilization.

Group Type: ACTIVE_COMPARATOR

Digital Incentive Spirometer

Intervention Type: DEVICE

This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer

Group 2

These study patients will be consented by members of the research team prior to surgery at their pre-operative clinic visit. The patient will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with a digital incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer, and will set a spirometry goal while collecting usage and pulmonary function data. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge.

Group Type: ACTIVE_COMPARATOR

Digital Incentive Spirometer

Intervention Type: DEVICE

This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer

Group 3

These study patients will be consented by a member of the research team prior to surgery at their pre-operative clinic visit. The patients will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with both intensive education reinforcement and the Jamboxx Respiratory Therapy Device that also includes multiple gaming programs. The games are meant to encourage incentive spirometry and are programmed to progress in accordance with the patient's personal increasing capacity. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge.

Group Type: EXPERIMENTAL

Digital Incentive Spirometer

Intervention Type: DEVICE

This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer

Jamboxx Respiratory Therapy Device

Intervention Type: DEVICE

THe Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet. With the Jamboxx Respiratory Therapy Device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.

Interventions

Digital Incentive Spirometer

This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer

Intervention Type: DEVICE

Jamboxx Respiratory Therapy Device

THe Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet. With the Jamboxx Respiratory Therapy Device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Post-op patients with elective upper abdominal surgery including but not limited to: bariatric surgery, cholecystectomy, and bowel surgery

Exclusion Criteria

• Patients who go directly to the ICU from the PACU post-surgery.
• Patients with visual impairments that make it difficult to understand written instructions
• Patients with hearing impairments that make it difficult to understand verbal instructions
• Patients who already receive supplemental oxygen therapy at home

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

My Music Machines Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilyn Fisher, MD

Role: STUDY_CHAIR

Albany Medical Center IRB

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

Other Identifiers

4R42HL132735-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Jamboxx RT Device Study 3

Identifier Type: -

Identifier Source: org_study_id