Dx–pH
Measurement System™ FAQs
What is the purpose of this test? What valuable information or
statistics can I procure and use to treat my patients?
The information provided by the Dx—pH Measurement System™ is
important in determining the impact of laryngopharyngeal reflux
on your patient’s symptoms. This test provides a graphical
representation of the pH activity over a 24 or 48-hour study. This
data is valuable as it relays information about your patient’s
reflux patterns in a clear fashion. Some ask why this is better
than laryngoscopy. With a laryngoscopy, the observer can evaluate
the severity of the damage the tissue sustained, but cannot determine
whether it is the result of reflux, vocal strain, coughing or another
source and when it occurs.
What clinical evidence is available to confirm that the Restech
system works in the oropharynx, compared to traditional pH pharyngeal
sensors used to measure pH above the UES?
Studies conducted with conventional pH catheters placed above the
upper esophageal sphincter (UES) have demonstrated repeated failure
for reliable pH measurement. Conventional pH-metry is dependent
on immersion in liquid to read pH. Until now, a self-condensing
sensor (one that does not require immersion in liquid) was not
available. When reflux is aerosolized, conventional pH sensors
are incapable of reliably measuring the pH. Restech’s Dx–pH
Probe™ contains a miniature sensor that rests in the tip
of a teardrop shaped catheter. The unique shape keeps the sensor
pointed down, where it reads the aerosolized reflux. Due to the
unique configuration and positioning of the pH sensor, Restech
has virtually eliminated the problem of false negatives.
How well tolerated is the Dx–pH Probe? Is there clinical
data related to the QOL/patient tolerance of the Dx–pH Probe?
Can patients eat, drink, and sleep with ease?
The Dx–pH Probe is tolerated very well by patients in most
everyday circumstances. Because it rests well above the epiglottis,
the swallowing mechanism is not interuppted. Also because of this
position, the Probe can be worn for up to 48 hours as it does not
irritate the throat. Michael Vaezi, MD, Vanderbilt University,
will be conducting a study on patient tolerance as compared to
traditional means in attempts to quantify the comfort of this probe.
What is the reimbursement level?
CMS reimburses in the range of $200 to $350 for CPT 91034 depending
on locality code. If appropriate, the visit is often coded with
an E and M code (99211-00215) in addition to 91034. Third parties
usually reimburse more than CMS. Usual and customary charges fall
at $560 for the 50th percentile and $1,021 for the 90th percentile. Where is the device being used?
Beyond administration in private practices and hospitals around
the country, the University of Southern California, Emory University,
Stanford University, Vanderbilt University, Medical College
of Wisconsin, University of Arkansas, University of California
San Diego, and Walter Reed Army Medical Center are presently
using the device.
Can it be used in children?
Yes, the Dx–pH Probe can be used in children, even infants.
Studies conducted by a pediatric pulmonologist in Ventura, CA
have been performed in babies as young as three months.
Can the Dx–pH Measurement System be used in sleep labs
concurrently with a sleep test?
The Restech "plug & play" Dx-Sleep Adapter™ accessory,
released February 2006, allows sleep medicine professionals to
track patients' airway pH events in real-time on their existing
monitoring equipment. The Dx–System can be easily set up
in a sleep clinic or physician's office. Since the device transfers
data using wireless telemetry, there are no extra leads from
the patient.
Can the Bravo™ be used
concurrently with the Dx–pH
Measurement System?
Yes, the Dx–pH Measurement System has a miniature 1.5mm
Probe that is inserted trans-nasally, with a resting position
posterior to the uvula. The Bravo system and Dx–System
use different data transmission and recording devices, which
can be used simultaneously. Presently, Dr. Tom DeMeester, Keck
School of Medicine, USC (also head of Restech’s Scientific
Advisory Board) is performing concurrent testing on patients
using the Bravo and the Dx–pH
Probe.
Why would I perform this test if I may have to perform a lower
esophageal test as well?
The test is performed on patients whom you suspect have laryngopharyngeal
reflux that is causing certain symptoms such as cough, throat
clearing, hoarseness, etc. If the Dx–System test reveals
episodes of lowered pH, the reflux can be treated in accordance
to the symptoms. If a patient presenting the same symptoms reveals
no change in pH, the reflux may not be causing the symptoms.
Can the probe be placed deeper in the airway, or in the esophagus?
Yes, the Dx–pH Probe can record liquid pH in the esophagus
as well as aerosolized pH in the oropharynx. The placement of
the Probe in the oropharynx, posterior to the uvula, seems to
be the most comfortable location for the patient and the clinical
results from this location accurately display supraesophageal
pH levels attributable to gastric reflux events. Positioning
the Probe in the lower pharyngeal area is possible, although
not recommended because of possible patient discomfort.
How does the Dx–pH Probe
stay in place?
After the probe is positioned, we recommend securing it using
Tegaderm™ tape as close to the naris as possible. This
will ensure that the probe does not slip out of the place. The
catheter is constructed with a pliable plastic material that
naturally wants to straighten out after curving through the nasal
cavity. This helps keep the sensor pointing downward for optimum
pH measurement.
Does the Dx—pH Measurement System™ measure
aerosolized pH, liquid pH, or both?
The Dx–pH Probe was designed specifically for the purpose
of measuring the pH of aerosolized reflux. It is extremely sensitive
and can obtain readings from very little reflux action. The Dx–pH
Probe does in fact work in a liquid environment, but because
of its position above the upper esophageal sphincter (UES), its
contact with refluxate is limited mainly to aerosol. This is
because the UES acts as a final barrier to protect the delicate
laryngeal tissue from acid exposure. Impedance technology has
revealed that it is extremely rare to get a liquid event above
the UES, and that nearly all events in this location are gaseous.
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