Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison
NCT ID: NCT00626366
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2008-03-12
2009-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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Nasal spray
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast Solution
Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
Nasal drop
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 mg I/mL
Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
Interventions
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Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast Solution
Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
Omnipaque 240 mg I/mL
Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of sinus surgery
* symptomatic deviated septum
* active seasonal allergies
* allergies to contrast
* history of nasal polyposis
* pregnant or breast feeding women
* neck or back problems that would prevent a subject from kneeling on the floor and crouching over
* currently taking metformin or amiodarone
* students or stff under the direct supervision of the investigators
* cognitive impairment
* terminal illness
19 Years
ALL
Yes
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Erin K O'Brien, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Donald Leopold, MD
Role: STUDY_CHAIR
University of Nebraska
Locations
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ENT Specialist PC of Omaha
Omaha, Nebraska, United States
Countries
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References
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Senocak D, Senocak M, Bozan S. Sinonasal distribution of topically applied particles: computerized tomographic detection and the effects of topical decongestion. Otolaryngol Head Neck Surg. 2005 Dec;133(6):944-8. doi: 10.1016/j.otohns.2005.08.024.
Olson DE, Rasgon BM, Hilsinger RL Jr. Radiographic comparison of three methods for nasal saline irrigation. Laryngoscope. 2002 Aug;112(8 Pt 1):1394-8. doi: 10.1097/00005537-200208000-00013.
Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.
Boatsman JE, Calhoun KH, Ryan MW. Relationship between rhinosinusitis symptoms and mucociliary clearance time. Otolaryngol Head Neck Surg. 2006 Mar;134(3):491-3. doi: 10.1016/j.otohns.2005.10.045.
Lund VJ, Black JH, Szabo LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.
Aukema AA, Fokkens WJ. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med. 2004;3(2):97-105. doi: 10.2165/00151829-200403020-00004.
Cannady SB, Batra PS, Citardi MJ, Lanza DC. Comparison of delivery of topical medications to the paranasal sinuses via "vertex-to-floor" position and atomizer spray after FESS. Otolaryngol Head Neck Surg. 2005 Nov;133(5):735-40. doi: 10.1016/j.otohns.2005.07.039.
Other Identifiers
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0498-07-FB
Identifier Type: -
Identifier Source: org_study_id
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