Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal

Televex videofluoroscopy utilizes real-time, x-ray imaging to visualize the velopharyngeal
port from multiple views or planes. The views generally utilized include the lateral, base
and frontal. This technique requires the subject to provide specific speech patterns, as
presented by a speech pathologist, while a radiologist obtains adequate views of the
velopharyngeal (VP) port. Each procedure will take about 3 to 5 minutes. Fluoroscopic imaging
is provided only during speech tasks and swallowing limiting radiation exposure.

1) The radiologist begins by taking a lateral view while speaking, which allows viewing of
the velum and posterior pharyngeal wall during speech production, as well as evaluation of
cranial base angle, size and location of adenoid tissue, velar length, velar thickness and
velar stretch. 2) The speech pathologist gives the subject barium sulfate contrast,
approximately 2 to 4 oz, to swallow, which allows for better structure delineation, as well
as the confirmation of the presence of palatal fistulae if barium passes through the palate
during swallowing. 3) The speech pathologist places the subject in a supine position and
barium sulfate is then instilled into the nasal passages bilaterally via syringe,
approximately 5 ml. approximately 2. 5 ml in each nostril. This allows for nasopharyngeal
coating of structures. 4) The speech pathologist then places the subject in the prone on the
table and positioned into a sphinx position with head and neck extended and forearms and
palms flat on the fluoroscopic table. The head, shoulders and neck are positioned to find the
base view of the velopharyngeal port. This view affords the ability to obtain velopharyngeal
closure patterns and size of velopharyngeal defect similar to that of nasopharyngoscopy. 5)
The next view obtained by the radiologist is the frontal or anterior-posterior. This is
obtained with the head/neck extended to allow for evaluation of the degree of lateral
pharyngeal wall motion. 6) The final view obtained by the radiologist is a repeat of the
initial lateral view this time with the nasopharyngeal coating in place. This can be
beneficial in confirming VPI in the presence of a small VP gap. During the coated lateral
view blowing of barium through the VP port can be observed. Additionally if barium is not
dissipated during velopharyngeal closure this can be indicative of anatomic VPI. This is all
done in the radiology department and takes approximately 3 minutes to 5 minutes.

Inclusion Criteria:

- All subjects for this study are adults.

- In this study, the most significant risk is that of radiation exposure, which for
Televex videofluoroscopy, is comparable to a single undergoing a single x-ray study,
and is significantly less than most CT scans.

- There are no risks to a fetus or pregnant subject involved in this study, nor are
there any interventions involved in the research that may be associated with
reproductive risks, because all female participants will be given a urine pregnancy
test prior to undergoing the Televex Videofluoroscopy.

- All participants will wear protective lead torso and pelvic shields, which are
standard for all personnel in a room where a radiologic evaluation is being performed.

Exclusion Criteria:

- The subjects for this study are all adult.

- None of the participants will be children because we are looking for subjects who have
reached skeletal maturity which happens around the age of 18 years old

- Any positive urine pregnancy test results would exclude the female subject from this
study.