Chronic Sinusitis
Conditions
Keywords
Nasal Spray, Nasal Drop, Intranasal Medication
Brief summary
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.
Detailed description
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.
Interventions
RADIATIONSinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
DRUGOmnipaque 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.
DRUGOmnipaque 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.
Sponsors
University of Nebraska
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult able to perform activities of daily living
Exclusion criteria
* signs or symptoms of acute or chronic paranasal sinus disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure the Distribution of Nasal Sprays and Drops. | 2 months | CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Nasal Drops 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Nasal Drops | Total | Nasal Spray |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Continuous | 28.6 years | 28.6 years | 28.6 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 18 participants | 9 participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
To Measure the Distribution of Nasal Sprays and Drops.
CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.
Time frame: 2 months
Population: Each participant's CT scan will be scored for left and right sides for a total of 18 sinonasal cavities
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Nasal vestibule | 18 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior olfactory cleft | 1 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior olfactory cleft | 1 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Sphenoethmoid recess | 2 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Inferior upper nasal vault | 16 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Superior upper nasal vault | 0 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior floor of nose | 12 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior inferior meatus | 16 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior inferior nasal cavity | 15 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior floor of nose | 9 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior inferior meatus | 9 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior inferior nasal cavity | 3 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior middle nasal cavity | 3 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior middle nasal cavity | 2 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior middle meatus | 4 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Anterior ethmoid | 2 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Osteomeatal complex | 2 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior middle meatus | 2 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Posterior ethmoid | 1 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Frontal recess | 0 nasal cavities (right and left sides) |
| Nasal Spray | To Measure the Distribution of Nasal Sprays and Drops. | Nasopharynx | 8 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior floor of nose | 0 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior middle nasal cavity | 5 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior middle meatus | 2 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior middle nasal cavity | 4 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior inferior meatus | 1 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior ethmoid | 1 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior middle meatus | 1 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior ethmoid | 2 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Sphenoethmoid recess | 4 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Nasal vestibule | 17 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior inferior nasal cavity | 1 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Inferior upper nasal vault | 17 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Nasopharynx | 2 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Superior upper nasal vault | 6 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior olfactory cleft | 4 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior floor of nose | 4 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Osteomeatal complex | 1 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior inferior meatus | 0 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Posterior olfactory cleft | 4 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Anterior inferior nasal cavity | 6 nasal cavities (right and left sides) |
| Nasal Drops | To Measure the Distribution of Nasal Sprays and Drops. | Frontal recess | 2 nasal cavities (right and left sides) |