Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2008-05-31
2015-09-30
Brief Summary
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No-one knows if there are differences between the different kinds of tubes regarding complications.
The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.
To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Insertion of a specific type of ventilation tube through the tympanic membrane
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear.
The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested.
The first combination will test:
"Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone)
The second combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone)
The third combination will test:
"Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone)
The fourth combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)
Interventions
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Insertion of a specific type of ventilation tube through the tympanic membrane
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear.
The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested.
The first combination will test:
"Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone)
The second combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone)
The third combination will test:
"Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone)
The fourth combination will test:
"Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous insertion of ventilation tube
1 Year
10 Years
ALL
No
Sponsors
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Centre for clinical research Vastmanland
UNKNOWN
Danderyd Hospital
OTHER
Responsible Party
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Magnus von Unge
Principal investigator
Principal Investigators
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Magnus von Unge, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ENT-dept Karolinska Hospital
Johan Knutsson, MD
Role: STUDY_DIRECTOR
Centre for clinical research Vastmanland
Locations
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Danderyds Hospital
Stockholm, Stockholm County, Sweden
Countries
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Other Identifiers
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2008/69-31/3
Identifier Type: -
Identifier Source: org_study_id
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