Eustachian Tube DysfunctionNCT05229380
Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube
An observational study of Eustachian Tube Dysfunction, run by Assiut University.
Trial summary
The eustachian tube (ET) performs three primary functions: pressure equalisation between the nasopharyms and middle ear: clearance of mucus from the middle ear, and prevention of sound or fluid reflux from the nasopharynx(1) .In individuals suffering from custachian tube dysunction (ETD), the tube opening may be… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Saccharin test
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data were collected and analyzed using SPSS (Statistical Package for the Social Science, version 20, IBM, and Armonk, New York). Continuous data were expressed in form of mean ± SD while nominal data were expressed in form of frequency (percentage). Frequency tables and charts were used . Chi²-test was used to compare the nominal data of different groups in the study. The level of confidence was kept at 95% hence a P value <0.05 indicated a significant association.
Who may be able to join
- 1-Patients diagnosed with tubotympanic type of CSOM during quiescent stage (dry perforation).
Who cannot join
- Active stage of tubotympanic CSOM (wet , discharging perforation).
- Patients with atticoantral type of CSOM.
- Patients with gross anatomical deformity or disease that can affect the result of tympanoplasty e.g cleft palate, severly deviated septum , adenoid, allergy , sinonasal polypi , otomycosis and presence of foci of infection.
- Patients with previous ear surgery .
- Patients with lost taste sensation .
- Patients with sensorineural hearing loss
About this study
The eustachian tube (ET) performs three primary functions: pressure equalisation between the nasopharyms and middle ear: clearance of mucus from the middle ear, and prevention of sound or fluid reflux from the nasopharynx(1) .In individuals suffering from custachian tube dysunction (ETD), the tube opening may be obstructed(2) resulting in the typical complaints of ear fullness, muffled hearing, or tinnitus(3). Less frequently, the ET may be permanently patulous, resulting in the symptoms of aural pressure or autophony (4). Adequate Eustachian tube function (ETF) is necessary for successful middle ear surgery. Studies of eustachian tube patency have been studied by the Politzer, Valsalva, and Toynbee maneuvers. In other cases it has been accomplished by testing air transport through the eustachian tube by tympanometry, sonotubometry, and air pressure equalization technique. However, these methods do not evaluate the drainage function (5). Saccharin is a nonnutritive sweetener. It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa. It can be used to assess mucocilliary function of nasal mucosa, without itself hampering it. The saccharin test seems to provide adequate information of the mucociliary function and patency of the ET (6) . Methylene blue is a chemical compound. It can be used to check patency of (ET). The dye, because of its liquid form, gravitates through the ET to the nasopharynx. So the objective of the dye is to establish the anatomical presence or absence of tube patency.
Read the detailed description
- Full history taking, general and Complete otolaryngology examination to ride at any pathologies and focus of infection which could influence the result of tympanoplasty.
- Audiological evaluation will be done for all patients both preoperatively and postoperatively
- Computed Tomography scanning of the mastoids will be done for all cases to rule out mastoiditis of any type
- Otoscopic examination size and site of perforation will be noted. The condition of middle ear mucosa, annulus, handle of malleus, and remnant of tympanic membrane (TM) will also be noted.
- Diagnostic Nasal Endoscopy: detailed nasal examination will be carried out. The nasal findings and the condition of the ET orifice will be noted.
- Saccharin test : Within two weeks before the surgery, the test will be performed. First, the taste response of patient to saccharin solution will br tested. With the patient seated and head tilted to the other ear , two drop of sterile sweety saccharin solution (one teaspoon saccharin granules dissolved in 10 ml sterile water) will placed in the middle ear through the TM defect by a dropper. The time required for the patient to taste the saccharin (ie, saccharin perception time [SPT]) will then measured.
- Methylene Blue Test: Within two weeks before the surgery, the test will be performed. The nose is first prepared by applying a nasal pack soaked in a solution composed of mixture of xylometazoline hydrchloride 0.1% and xylocaine 10% (1:1) for 10 minutes. Then 0- degree sinscope (Karl storz, Germany) will passed through the nose till an adequate view of the nasopharyngeal opening of the ET is obtained. Two to three drops of sterile methylene blue dye will placed in the middle ear through the TM defect after tilting the patients head towards the opposite ear.
- Within a week of evaluation of ETF, patients will be operated on for type 1 tympanoplasty after 3 weeks patients are reviewed for inspection of the operated ear. The second and third postoperative reviews will be done at 2 months and 6 months, respectively Patients were evaluated postoperatively by otoscopy, tympanometry, and audiometry.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Saccharin test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharin testDrug
Also called methyelne blue
Saccharin is a nonnutritive sweetener. It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa. Methylene blue is a chemical compound. It can be used to check patency of (ET). The dye, because of its liquid form, gravitates through the ET to the nasopharynx.
| Study group | Role | What they receive |
|---|---|---|
| saccharin test | The patients with SPT less than 20 minutes are considered to have a normally functioning ET.
The patients with SPT between 20- 45 minutes are considered to have a partial dysfunction of ET .
The patients with SPT more than 45 minutes are considered to have a gross dysfunction of the ET . Receives: Drug: Saccharin test | |
| methylene blue test | The patients with methylene blue clearance time less than 10 minutes are considered to have a normally functioning ET.
The patients with methylene blue clearance time between10 to 20 minutes are considered to have a partial dysfunction of ET.
The patients with methylene blue clearance time more than 20 minutes are considered to have a gross dysfunction of the ET . Receives: Drug: Saccharin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
out come of tympanoplasty
Tympanoplasty was considered successful if graft healing was noticed together with a mean of postoperative air bone gap of 20 dB or less at frequencies of 500,1000, 2000,4000 dB.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start28 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demiana Emad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229380
- Sponsor's protocol ID
- DEmadtympanoplasty
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube
- ClinicalTrials.gov ID
- NCT05229380
- Acronym / sponsor ID
- DEmadtympanoplasty
- Conditions
- Eustachian Tube Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The eustachian tube (ET) performs three primary functions: pressure equalisation between the nasopharyms and middle ear: clearance of mucus from the middle ear, and prevention of sound or fluid reflux from the nasopharynx(1) .In individuals suffering from custachian tube dysunction (ETD), the tube opening may be obstructed(2) resulting in the typical complaints of ear fullness, muffled hearing, or tinnitus(3). Less frequently, the ET may be permanently patulous, resulting in the symptoms of aural pressure or autophony (4). Adequate Eustachian tube function (ETF) is necessary for successful middle ear surgery. Studies of eustachian tube patency have been studied by the Politzer, Valsalva, and Toynbee maneuvers. In other cases it has been accomplished by testing air transport through the eustachian tube by tympanometry, sonotubometry, and air pressure equalization technique. However, these methods do not evaluate the drainage function (5). Saccharin is a nonnutritive sweetener. It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa. It can be used to assess mucocilliary function of nasal mucosa, without itself hampering it. The saccharin test seems to provide adequate information of the mucociliary function and patency of the ET (6) . Methylene blue is a chemical compound. It can be used to check patency of (ET). The dye, because of its liquid form, gravitates through the ET to the nasopharynx. So the objective of the dye is to establish the anatomical presence or absence of tube patency.
Detailed description
- Full history taking, general and Complete otolaryngology examination to ride at any pathologies and focus of infection which could influence the result of tympanoplasty.
- Audiological evaluation will be done for all patients both preoperatively and postoperatively
- Computed Tomography scanning of the mastoids will be done for all cases to rule out mastoiditis of any type
- Otoscopic examination size and site of perforation will be noted. The condition of middle ear mucosa, annulus, handle of malleus, and remnant of tympanic membrane (TM) will also be noted.
- Diagnostic Nasal Endoscopy: detailed nasal examination will be carried out. The nasal findings and the condition of the ET orifice will be noted.
- Saccharin test : Within two weeks before the surgery, the test will be performed. First, the taste response of patient to saccharin solution will br tested. With the patient seated and head tilted to the other ear , two drop of sterile sweety saccharin solution (one teaspoon saccharin granules dissolved in 10 ml sterile water) will placed in the middle ear through the TM defect by a dropper. The time required for the patient to taste the saccharin (ie, saccharin perception time [SPT]) will then measured.
- Methylene Blue Test: Within two weeks before the surgery, the test will be performed. The nose is first prepared by applying a nasal pack soaked in a solution composed of mixture of xylometazoline hydrchloride 0.1% and xylocaine 10% (1:1) for 10 minutes. Then 0- degree sinscope (Karl storz, Germany) will passed through the nose till an adequate view of the nasopharyngeal opening of the ET is obtained. Two to three drops of sterile methylene blue dye will placed in the middle ear through the TM defect after tilting the patients head towards the opposite ear.
- Within a week of evaluation of ETF, patients will be operated on for type 1 tympanoplasty after 3 weeks patients are reviewed for inspection of the operated ear. The second and third postoperative reviews will be done at 2 months and 6 months, respectively Patients were evaluated postoperatively by otoscopy, tympanometry, and audiometry.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saccharin test | – | Drug: Saccharin testThe patients with SPT less than 20 minutes are considered to have a normally functioning ET. The patients with SPT between 20- 45 minutes are considered to have a partial dysfunction of ET . The patients with SPT more than 45 minutes are considered to have a gross dysfunction of the ET . |
| methylene blue test | – | Drug: Saccharin testThe patients with methylene blue clearance time less than 10 minutes are considered to have a normally functioning ET. The patients with methylene blue clearance time between10 to 20 minutes are considered to have a partial dysfunction of ET. The patients with methylene blue clearance time more than 20 minutes are considered to have a gross dysfunction of the ET . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data were collected and analyzed using SPSS (Statistical Package for the Social Science, version 20, IBM, and Armonk, New York). Continuous data were expressed in form of mean ± SD while nominal data were expressed in form of frequency (percentage). Frequency tables and charts were used . Chi²-test was used to compare the nominal data of different groups in the study. The level of confidence was kept at 95% hence a P value <0.05 indicated a significant association.
Key inclusion criteria (1 listed)
- 1-Patients diagnosed with tubotympanic type of CSOM during quiescent stage (dry perforation).
Key exclusion criteria (6 listed)
- Active stage of tubotympanic CSOM (wet , discharging perforation).
- Patients with atticoantral type of CSOM.
- Patients with gross anatomical deformity or disease that can affect the result of tympanoplasty e.g cleft palate, severly deviated septum , adenoid, allergy , sinonasal polypi , otomycosis and presence of foci of infection.
- Patients with previous ear surgery .
- Patients with lost taste sensation .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharin testAlso: methyelne blueSaccharin is a nonnutritive sweetener. It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa. Methylene blue is a chemical compound. It can be used to check patency of (ET). The dye, because of its liquid form, gravitates through the ET to the nasopharynx. | Drug | methylene blue test, saccharin test |
Primary outcome
out come of tympanoplasty
Time frame: 2 years
Tympanoplasty was considered successful if graft healing was noticed together with a mean of postoperative air bone gap of 20 dB or less at frequencies of 500,1000, 2000,4000 dB.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Prasad KC, Hegde MC, Prasad SC, Meyappan H. Assessment of eustachian tube function in tympanoplasty. Otolaryngol Head Neck Surg. 2009 Jun;140(6):889-93. doi: 10.1016/j.otohns.2009.02.015. Epub 2009 Apr 8. PMID: 19467410.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Eustachian Tube Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
out come of tympanoplasty (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.