The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | October 1, 2018 |
| End Date: | June 30, 2019 |
| Contact: | Maria DiSanto-Rose, RN |
| Email: | maria@jamboxx.com |
| Phone: | (518) 262-2269 |
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 3: Post-Op Inpatients for Short Term Evaluation of Atelectasis
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.
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.
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.
• 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.
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
We found this trial at
1
site
Albany, New York 12208
Principal Investigator: Thomas Smith, MD
Phone: 518-817-8798
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