Observation of Gas Exchange in the Middle Ear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00794105
Recruitment Status : Unknown
Verified November 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 19, 2008
Last Update Posted : November 19, 2008
Information provided by:
Shaare Zedek Medical Center

Brief Summary:

Observation of fluid behavior over a perforated eardrum.

A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.

Condition or disease
Normal Middle Ears. Otitis Media Ears.

Detailed Description:

Fluid present in middle ears is observed during the regular treatment of patients.

The observation in made during the treatment and not as an additional activity. The fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation [considered as the normal ears] compared to otitis media ears.

The observation is made on bubble formation over the perforation. The time length of the inspection is about 1 minute, under the microscope, during the treatment.

Study Type : Observational
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Normal ears
Otitis media ears.

Primary Outcome Measures :
  1. Creation of air bubbles. [ Time Frame: one year. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.

Inclusion Criteria:

  • Patients having perforated eardrum.

Exclusion Criteria:

  • Non cooperative patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00794105

Contact: David Cohen, MD + 972 50 8685888

Otolaryngology Dept., Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center

Responsible Party: David Cohen, MD, Shaare Zedek Medical Center Identifier: NCT00794105     History of Changes
Other Study ID Numbers: cohenmed.CTIL
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by Shaare Zedek Medical Center:
Middle ear

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases