Tympanostomy Tube Extrusion Time & Viscosity

OTITIS MEDIA WITH EFFUSION Clinical Trial

Official title:

The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848026
• Other study ID #: B.30.2.BAV.0.05.05/468
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: August 2019
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Studies have focused on the factors that influence tympanostomy tube (TT) extrusion may contribute to the management of OME. In this study the investigators aimed to assess the correlation between the TT extrusion time and viscosity of the middle ear fluid. 33 patients scheduled for TT insertion included in the study. During the paracentesis, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. After the surgery, patients were controlled monthly until the tubes were seen extruded.The analysis of the correlation between tube extrusion time and viscosity was insignificant (p >0.05).

Description:

45 patients were evaluated in the outpatient clinic of the Bezmialem Vakif University Department of Otorhinolaryngology. OME was diagnosed by endoscopic-otoscopic examination findings and type-B tympanograms. Patients who do not have a previous history of TT insertion and retraction pocket included in the study. They were all scheduled for Shepard TT insertion. 12 patients were excluded for not coming to their postoperative controls properly. Total of 33 patients' data were analyzed in the end. During the paracentesis, myringotomy incision was done at the anteroinferior quadrant. Fluid from the middle ear was obtained by using 22 gauge syringe, and the viscosity was measured with a viscometer. Since the viscosity in most patients was mucoid in appearance, the patients were subdivided into two groups according to median viscosity level to determine whether higher or lower viscosity of the effusion impacted tympanostomy tube extrusion time. Patients with an effusion below and above the median viscosity value of 439 centipoise (cP) were assigned to Group 1 and 2, respectively. After the surgery, patients were controlled monthly until the tubes were seen extruded.Brookfield DV-II+ProCP Viscometer (Brookfield Engineering Laboratories, Inc., Massachusetts, USA) was used for viscosity measurements. This viscometer was able to measure the viscosity of fluid samples as small as 0.5 ml. The results of the viscosity measurements were recorded as cP units. The patients were investigated for any correlation between the viscosity level of the effusion and extrusion time of the TT. Descriptive statistics were presented as mean and standard deviation. T-test was used to estimate the correlation between the parameters. Mann-Whitney U Test was used to compare the two groups. Statistical analyses were conducted with the IBM SSPS 22.0 program. Significance level was set at 0.05 for all tests. All the procedures were approved and performed in accordance with the ethical standards of the relevant national and institutional guidelines on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Permission for the study was obtained from Institutional Ethics Committee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 25, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 53 Years

Eligibility

Inclusion Criteria:

• endoscopic-otoscopic examination findings of serous otitis media

• type-B tympanograms

• None existence of a previous history of TT insertion

• None existence of a retraction pocket

Exclusion Criteria:

• Patients who do not come to their postoperative controls

• existence of a previous history of TT insertion

• existence of a retraction pocket

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Other:
• Middle ear fluid viscosity
The patients were subdivided into two groups according to median viscosity level
• Tympanostomy tube extrusion time
Tympanostomy tube extrusion time of the all patients recorded prospectively.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean tube extrusion time	Mean tube extrusion time of total 33 patients was measured	2 year
Primary	The correlation between tube extrusion time and viscosity	The correlation between tube extrusion time and viscosity was analyzed	2 year