Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube

NCT05229380 | Unknown

• 1 other identifier: DEmadtympanoplasty
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

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 .

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 .

Drug: Saccharin test

Interventions

Saccharin test DRUG

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.

Also known as: methyelne blue

methylene blue test; saccharin test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients diagnosed with tubotympanic type of CSOM during quiescent stage (dry perforation).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Links

• 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.

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demiana emad thabet

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 8, 2022
• Study Start: February 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-01