Trial document




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  DRKS00009327

Trial Description

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Title

Impact of tympanic membrane baroreceptors on Eustachian tube function

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The eustachian tube (ET) is involved in drainage regulation, protection, and pressure equalization in the middle ear. Consequently, middle ear pathologies are often associated with ET dysfunction. It is assumed that tympanic membrane barorecepters play an important role concerning the function of pressure equalization of the eustachian tube.
Ingelstedt et al. introduced the method of continuously measuring the impedance of the tympanic membrane in a pressure chamber to evaluate ET function. The diagnostic impedance measurement performed in the pressure chamber enables a dynamic evaluation of the ET by equalizing the pressure in the tympanic cavity and
measuring different parameters such as the ETOP (or ET closing pressure [ETCP]) and the ET opening duration (ETOD).
In this study we compared eustachian tube function parameters in measurments before and after local anasthesia of the baroreceptors to estamate the impact of the tympanic membrane baroreceptors on eustachian tube function.

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Organizational Data

  •   DRKS00009327
  •   2015/09/08
  •   [---]*
  •   yes
  •   Approved
  •   15-111, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   cholesteatoma, acute and chronical tube dysfunction
  •   H71 -  Cholesteatoma of middle ear
  •   H69.8 -  Other specified disorders of Eustachian tube
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Interventions/Observational Groups

  •   1. ENT status including examination of the ear and epipharynx
    2. Pressure rising and decompression (standardized pressure profile), meanwhile continously measurement of the tympanic impedance (duration of the measurment: 6 minutes)
    3. Application of local anaesthesia onto one of the tympanic membranes
    4. Removal of the local anaesthesia after 5 minutes
    5. Second measurment in the pressure chamber following the same pressure profile as described in 2. (duration of the measurment: 6 minutes)
    6. Final ENT status including examination of the ear and discharge
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

ET opening pressure, ET opening duration, ET opening
frequency, and ET closing pressure will be determined before
and after local anaesthesia of the tympanic membrane

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Secondary Outcome

- is a pressure equalization possible (yes/no)
- complete or incomplete openings of the eustachian tube during compression or decompression
- analysis of pressure progress

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/10/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

ear-healthy participants between the age of 18 and 70 years

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Exclusion Criteria

- pregnancy,
- claustrophobia,
- exclusion if any operation was done on the ears,
- concurrent cold,
- inserted grommets or
- perforation of the tympanic membrane,
- adenoid hypertrophy,
- gastroesophageal reflux diseases, and
- signs and/or symptoms indicative of active allergic rhinitis.

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Addresses

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    • Klinik und Poliklinik für HNO, Kopf- und HalschirurgieKlinikum der Universität zu Köln
    • Mr.  Prof  Dirk  Beutner 
    • Kerpener -Str. 62
    • 50937 Köln  Köln
    • Germany
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    • Klinik und Poliklinik für HNO, Kopf- und HalschirurgieKlinikum der Universität zu Köln
    • Mr.  Dr.  Moritz Friedo  Meyer 
    • Kerpener -Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für HNO, Kopf- und HalschirurgieKlinikum der Universität zu Köln
    • Mr.  Dr.  Moritz Friedo  Meyer 
    • Kerpener -Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik KölnHals-Nasen-Ohren Klinik
    • Mr.  Dr.  Moritz Friedo  Meyer 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Passiver Tubendruckausgleich in einer hypobaren/hyperbaren Druckkammer
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* This entry means the parameter is not applicable or has not been set.