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Observation of Gas Exchange in the Middle Ear

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00794105
First received: November 18, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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
Normal Middle Ears.
Otitis Media Ears.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

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

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Creation of air bubbles. [ Time Frame: one year. ] [ Designated as safety issue: No ]

Study Start Date: November 2008
Groups/Cohorts
Normal 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.

  Eligibility

Ages Eligible for Study:   8 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Patients having perforated eardrum.

Exclusion Criteria:

  • Non cooperative patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794105

Contacts
Contact: David Cohen, MD + 972 50 8685888 cohendv@netvision.net.il

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

No publications provided

Responsible Party: David Cohen, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00794105     History of Changes
Other Study ID Numbers: cohenmed.CTIL
Study First Received: November 18, 2008
Last Updated: November 18, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
Gas
Middle ear

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013