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Digitrapper® pH-Z Monitoring

pH-Impedance Study Review

Discussion:
It is recommended that the physician or clinician who will be reviewing and interpreting the pH impedance
study be familiar with the techniques that are used in the placement of a pH probe. This includes the following:

§§ Confirming the accuracy of the pH probe position by manometric anatomical landmarks.

§§ Confirming the accuracy if x-ray verification was used. The physician or clinician must have an understanding of
the location of the pH sensor on the catheter relative to known anatomical landmarks on the radiographic
image.

§§ The physician or clinician must have a thorough understanding of Reflux Software protocol settings, and how
they may affect the resulting data.

Reviewing the Diary:

1. Double-click on the Reflux Software desktop icon.

2. Click the Open button on toolbar to select study from the Study Manager to analyze an existing study.

3. Select the patient file you wish to view and click Open.

4. Click on Guide then Next for step-by-step instructions for uploading and reviewing a reflux study.

5. Press Skip then Next to proceed with the analysis of the currently opened study.

6. Click on Diary and verify the following items have been entered:

§§ Verify all Meal start and end times have been entered,

§§ Verify all Supine start and end times have been entered.

§§ Verify that all symptoms have been entered.

§§ Verify that the selected protocol is correct. If this is not correct, use the drop down menu to select the correct
protocol.

Note: Meal and Supine events should be present within the diary section. If they are missing, the report
outputs may be incomplete. Symptom events should have a name and should not say Symptom. If Symptom
appears, select a specific symptom from the drop-down list.

Reviewing the pH Data:

7. Press “Next” to hide impedance data. This will allow viewing of the pH data more clearly. Press “Skip” to proceed to
the next step without hiding the impedance data.

Note: Hiding the impedance tracing is optional, but may provide a better picture of the overall pH tracing.
When both the pH tracing and impedance contour display is on together it will display the pH tracing
superimposed on the impedance tracing. Below the impedance contour is the same display of the pH tracing.
This should not be confused as an additional pH tracing.

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Digitrapper® pH-Z Monitoring

8. Review the pH trace(s) to determine if physiologically accurate and reflective of the patient’s history. Ensure:

§§ The pH baseline is not consistently at or below pH 4 for significant duration (possibly indicating catheter
migration towards the stomach or capsule detachment. See Image A)

§§ The pH baseline is not consistently high

§§ To exclude non-physiological data from being analyzed, press Exclude, and left click and drag the edges to
encompass data to be excluded. Data above pH 9 and below pH 0 will be automatically excluded.

9. Press “Next” to view the next time segment of the study.

10. Verify the study recording was ended before the catheter was removed from the patient. If the catheter was
removed before the end of the study recording, press Exclude, and left click drag the edges to encompass data
from the beginning of the catheter removal to the end of the study. Press Next to proceed. (See Image B)

11. The pH trace data review is complete. Press Next to proceed to the impedance data review. For frequently used
functions, a list of keyboard shortcuts are provided under the Library option in Help menu.

Reviewing the Impedance Data:

12. Press Next to set the software display magnification to 3 minutes. Zoom controls on the toolbar can be used to
set the display to preferred magnification for impedance data review. Impedance data can be viewed in Trace or
Contour mode depending on personal preference. “Ctrl + Q” may be used to toggle between the modes.

Note: Lower impedance baselines may be seen in some patient conditions such as Barett’s esophagus. (See
Image E).

13. Use the mouse or keyboard shortcuts to navigate to the next time segment of the study to:

§§ Add/Remove impedance episodes as necessary: To add or delete an impedance episode, right-click and select
Add Episode or Delete Episode at any instance. Impedance-detected reflux episodes can also be added or
deleted from the Tools menu or through the keyboard shortcuts.
§§ Adjust impedance episode boundaries: To adjust the width of an episode at any channel location, click-
and-drag the boundary markers. The orientation of the left side markers to each other determines whether
an episode is considered anterograde or retrograde. If more than half of the pair of channels have retrograde
movement, the episode is identified as reflux. (See Image C and D).

§§ Add/Remove proximal episodes as needed: If a reflux is to be extended to a proximal channel, place the red
time bar over the reflux, right-click and select Add Impedance Episode Top Channels, or use the corresponding
shortcut key. Similarly, Delete Impedance Episode Top Channels deletes the topmost channel of the reflux
located beneath the time bar. Adding or deleting channels can be done only sequentially, one channel at a time.

§§ When reviewing the impedance tracing, confirm symptom association with impedance or pH events. You may
also click directly on the symptom Diamond Icon in the main display time bar and that will take you to the
episode. A good time scale to view a symptom in is 2 minutes, with the symptom on the right edge of the
screen, since a reflux episode that occurs within the 2 minutes prior to a symptom has a positive association.
(See Image F)

14. Press Skip to proceed to Report Creation.

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Creating The Report:

15. When the study data review is complete, press Next for the report creation steps.

16. Press Next to open the Report form.

§§ Review patient information and analysis data

§§ Fill in the Procedure Description, Indications, Interpretation, Impressions and Physician Signature

§§ Press the Create button to open Create Report dialog

§§ Select the information to be included in the Report document, and create report
§§ Press the Close button in the Report Form

17. Press Save to save this reviewed study in the Study Repository.

18. Study successfully saved. Press Exit to close this software application.

Impedance Definitions
Liquid Only Reflux: A retrograde decrease of 50% in impedance from the baseline in the 2 distal impedance sensors
or more than half of the channel pairs should have bolus movement in retrograde direction. The impedance reflux
classification markers represent the pH value of the reflux episode as detected by impedance:

§§ Acid reflux: pH < 4

§§ Weakly acidic reflux: pH between 4-7

§§ Non-acid reflux: pH > 7

Gas Reflux: A simultaneous increase in impedance > 3,000 Ω in any 2 consecutive impedance sites with 1 site having an
absolute value > 7,000 Ω.

Keyboard Shortcuts

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Digitrapper® pH-Z Monitoring

Image A: Example of a pH probe placed too low in the esophagus

Image B: pH probe removed before end of study. This data must be excluded

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Image C: Contour mode showing anterograde (swallow) and retrograde (reflux) bolus movement

Image D: Line trace mode showing anterograde (swallow) and retrograde (reflux) bolus movement

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Image E: Lower impedance reading in distal two-thirds of esophagus

Image F: Heartburn symptom associated with weakly acid reflux

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