Procedures:
Recruitment:
To prevent any potential undue influence that may inadvertently occur due to patient
physician or patient coordinator relationships we have decided that the bariatric fellow
who has limited exposure to the patients in the office setting or in the lead up to
surgery, would be less likely to elicit this response. At the patient's final
pre-operative visit in the office prior to surgery the fellow will meet privately with
the patients He will discuss the device, utilizing educational materials and a video
provided by the device company and then explain the study to the patient, allowing time
for questions and reassuring them that care will be provided for PONV, regardless of
participation in the study. He will then obtain consent.
Application of band:
Reletex Band will be applied and turned on to setting #1 at completion of the
participant's bariatric sleeve surgery. Assessments will be done utilizing the Post
Operative Nausea and Vomiting (PONV) Impact Scale and the band settings will be titrated
per the protocol at hr 1and 2 in Post Anesthesia Care Unit (PACU).
Titration of band settings:
Upon arrival to the Surgical Floor at hour 3 an assessment utilizing PONV Impact Scale
and the band settings will be titrated per the established protocol. Assessments and
adjustments will continue every 4 hours per protocol thereafter. At hour 12, due to
battery life limitations, the band will be removed by the patient's RN and replaced with
a new band, (settings to continue from previous band).
At time of patient discharge (within the 24-hour postoperative timeframe), a final
assessment will be completed, and the band will be removed.
The voltage/dose for each level is as follows. R=500Ω Setting Level mAmps Amps Volts
(Amps * Resistance)
10 0.01 5
18 0.018 9
25 0.025 12.5
33 0.033 16.5
40 0.04 20
The band will be applied at the lowest level (1) and the power level will be increased
based on the PONV impact scale ratings and patient's comfort level with the stimulation
using the following titration scale:
Setting Level PONV Impact Score
0-2 (starting setting)
2-3
3-4
4-5
5 or greater The device lot number for each band (2 per patient), will be recorded
by the Bariatric Coordinator prior to placing in patient chart the am of surgery,
and maintained on an excel spreadsheet as a back-up method. Immediately following
the case, the Bariatric Fellow will apply the first band to the patient at a setting
of #1. He will enter the order for the band into Epic, at which time he will also
enter both band lot numbers- these #s will then be visible to staff when looking
back at the original order. In the recovery room the Bariatric Fellow will also
attach a clip-on pedometer to the patient's gown. Assessments of the patients PONV
risk rating, PONV impact scores, number of times anti-emetics are dispensed, and
Pain Assessments will be collected electronically utilizing the EHR with designated
documentation areas for these. In addition, to monitor postoperative ambulation,
patients will wear clip on pedometers, and these will be turned into Coordinator and
data will be recorded within the excel spreadsheets. As part of the
Coordinator/Clinical Reviewers normal data collection for MBSAQIP, all data will be
extracted from the patient chart, de-identified and summarized and stored on a
password protected computer with a secure server.
Collected data: The data will be extracted either manually or in a formulated report from
EPIC and then stored in REDCap or Excel. REDCap ensures data privacy and security through
a combination of features including: user-based access controls, encryption of data at
rest and in transit, detailed audit trails, data masking options, anonymous survey
capabilities, and the ability to restrict access to specific data fields based on user
roles, all while allowing researchers to customize security settings based on their
project needs and relevant regulations like HIPAA compliance. In the rare circumstance
that Excel will need to be utilized as a backup method, it will be stored on a password
protected Penn Medicine computer on a secure server with firewall protections.
Demographic data will be collected to describe the characteristics of the sample, such as
age, gender, ethnicity, race, and comorbidities. The demographic data form will not
contain names or identifying information.
PONV Risk Score Rating will be determined using a scale currently used within our EMR by
Anesthesia looking at validated risk factors for PONV such as, female gender, nonsmoker,
history of PONV or use of Postoperative opioids. Each risk is assigned 1 point the higher
the score the higher the patient is at risk for experiencing PONV.
PONV Incidents will be measured using the Simplified PONV impact scale to define
clinically significant PONV. This is a 2-item questionnaire that measures number of
episodes of vomiting or dry-retching, as well as the experience of nausea and if it has
interfered with normal activity. The PONV impact scale helps quantify vomiting intensity
based on the number of episodes of vomiting/retching using a Likert type scale for this
question with the following values: 0 = No, 1=once, 2= twice and 3=three or more times.
Question number 2 of the PONV impact scale, helps quantify the impact of nausea on the
patient based on how it interferes with their ability to perform activities of daily
living such as being able to get out of bed, move, walk, eat/drink. The following values
were assigned to this variable, 0=Not at all, 1 sometimes, 2 often or most of the time
and 3=All of the time. The 2 questions are combined to produce a score, a score greater
than or equal to 5 is considered clinically important PONV. (Myles and Wengritzky.,
2012).
Pain Assessment Scale:
Participants postoperative pain will be monitored and documented using an 11-point
Numerical Rating System, with "0" being no pain and "10" being the worst imaginable.
Patient Mobility:
Patients' mobility postoperatively will be assessed using a Pedometer.