The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3

NCT03547349 | Terminated DMC FDA Device

• 2 other identifiers: Jamboxx RT Device Study 34R42HL132735-02
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectases, Postoperative Pulmonary

Keywords

respiratory therapy; videogaming therapy; incentive spirometry; atelectases

Outcome Measures

Primary Outcomes (1)

• Severity of atelectasis

  Severity of atelectasis radiographically assessed on a 5 point scale (1. no apparent disease, 2. subsegmental atelectasis, 3. segmental atelectasis, 4. lobar atelectasis, or 5. pneumonia) by a chest radiologist and two pulmonary physicians blinded to study group assignment. Within this scale range, no apparent disease represents the best possible outcome, while pneumonia represents the worst possible outcome

  48 hours post-surgery

Secondary Outcomes (5)

• Device Utilization Time

  72 hours post surgery or time of discharge, whichever comes first

• Device Uses

  72 hours post surgery or time of discharge, whichever comes first

• Pulse Oximetry

  3x/ day (except between hours of 10pm and 6am) until 72 hour post-surgery mark or time of discharge, whichever comes first

• Clinically relevant events

  72 hours post surgery or time of discharge, whichever comes first

• Incidence of hospital acquired respiratory infection

  72 hours post surgery or time of discharge, whichever comes first

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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.

Device: Digital Incentive Spirometer

Group 2

ACTIVE COMPARATOR

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.

Device: Digital Incentive Spirometer

Group 3

EXPERIMENTAL

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.

Device: Digital Incentive Spirometer; Device: Jamboxx Respiratory Therapy Device

Interventions

Digital Incentive Spirometer 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 1; Group 2; Group 3

Jamboxx Respiratory Therapy Device 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.

Group 3

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• My Music Machines Inc.: lead
• Albany Medical College: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marilyn Fisher, MD

  Albany Medical Center IRB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Incidence and severity of atelectasis will be radiographically assessed on a 5 point scale (no apparent disease, subsegmental atelectasis, segmental atelectasis, lobar atelectasis, or pneumonia) by a chest radiologist and two pulmonary physicians blinded to study group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be enrolled sequentially in Group 1 until the desired group enrollment number is met (N=25) at which point participants will be randomized into groups 2 and 3, stratified by surgery type (open or laproscopic)

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 6, 2018
• Study Start: October 1, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)