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CompletedNCT03848026Updated Aug 8, 2019

Tympanostomy Tube Extrusion Time & Viscosity

An observational study in OTITIS MEDIA WITH EFFUSION, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 2 Years to 53 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
33
Ages
2 Years to 53 Years
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • OTITIS MEDIA WITH EFFUSION

Keywords

  • Otitis media
  • tympanostomy tube
  • viscosity
  • middle ear fluid
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's enrollment of 33 is below the median of 165 across 63 observational studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 53 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

33 patients who were diagnosed as otitis media with effusion and scheduled for Shepard TT insertion included in the study.

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

Exclusion Criteria:

  • Patients who do not come to their postoperative controls
  • existence of a previous history of TT insertion
  • existence of a retraction pocket
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
33 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Group 1

    middle ear fluid viscosity \<439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively

    Other: Middle ear fluid viscosity · Other: Tympanostomy tube extrusion time

  • Group 2

    middle ear fluid viscosity \>439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively

    Other: Middle ear fluid viscosity · Other: Tympanostomy tube extrusion time

Interventions

  • OtherMiddle ear fluid viscosity

    The patients were subdivided into two groups according to median viscosity level

  • OtherTympanostomy tube extrusion time

    Tympanostomy tube extrusion time of the all patients recorded prospectively.

06

What researchers measure

Primary outcomes

  1. Mean tube extrusion time

    Mean tube extrusion time of total 33 patients was measured

    Time frame: 2 year

  2. The correlation between tube extrusion time and viscosity

    The correlation between tube extrusion time and viscosity was analyzed

    Time frame: 2 year

07

Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Fatih 34093, Turkey
08

References and documents

Publications

  • Degirmenci N, Tugrul S, Goktas SS, Senturk E, Calim OF, Dogan R, Yenigun A, Ozturan O. The relationship between the tympanostomy tube extrusion time and viscosity. Int J Pediatr Otorhinolaryngol. 2020 Sep;136:110140. doi: 10.1016/j.ijporl.2020.110140. Epub 2020 May 27. PubMed 32554135 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03848026
Lead sponsor
Bezmialem Vakif University
Responsible party
Nazan Degirmenci (Principal Investigator, Bezmialem Vakif University) — Principal investigator
First posted
Feb 20, 2019
Start date
Jan 15, 2018
Primary completion
Jun 15, 2019
Completion
Jun 25, 2019
Last update
Aug 8, 2019

Study contacts

Nazan Degirmenci, MD
principal investigator · Bezmialem Vakif University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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