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Sponsored by: |
Children's Hospital of Pittsburgh |
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Information provided by: | Children's Hospital of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00773994 |
This prospective research study seeks to determine how the normal velopharyngeal mechanism compares, both anatomically and physiologically, with previous data obtained on subjects with submucous cleft palate (SMCP) in IRB#07080395.
Condition | Intervention |
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Cleft Palate |
Other: Normal Velopharyngeal Mechansim |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal |
Estimated Enrollment: | 10 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Normal velopharyngeal mechanism
All participants in this study are normal healthy adults, who have agreed to undergo to a videofluoroscopic Televex. These participants are acceptable control subjects because they are not diagnosed with VPI and/or submucous cleft palate (SMCP) and the velopharyageal mechanism functions the same in adults as it does in children. This procedure will take approximately 3 minutes to 5 minutes.
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Other: Normal Velopharyngeal Mechansim
The amount of radiation exposure that you will receive from this procedure is about 0.3 rem to the head and neck, with minimal exposure of the other body areas.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Matthew Ford`, MS | 412-692-6203 | matthew.ford@chp.edu |
Contact: Jennifer Szczepaniak, BS | 412-692-6203 | jennifer.szczepaniak@chp.edu |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh of UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Matthew Ford, MS 412-692-6203 matthew.ford@chp.edu | |
Contact: Jennifer Szczepaniak, BS 412-692-6203 jennifer.szczepaniak@chp.edu |
Principal Investigator: | Jennifer Szczepaniak, BS | Children's Hospital of Pittsburgh of UPMC |
Responsible Party: | Children's Hospital of Pittsburgh of UPMc ( Matthew Ford, MS ) |
Study ID Numbers: | 07100381 |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773994 |
Health Authority: | United States: Institutional Review Board |
anterior palatal eminence palatal elevation above the maxillary plane anterior uvular prolapse "inverted-V" present in base view. |
Mouth Diseases Cleft Palate Musculoskeletal Diseases Craniofacial Abnormalities Stomatognathic Diseases |
Maxillofacial Abnormalities Congenital Abnormalities Prolapse Musculoskeletal Abnormalities |
Mouth Abnormalities Jaw Diseases Stomatognathic System Abnormalities Jaw Abnormalities |