Tympanic Membrane PerforationNCT01766856
Eustachian Tube Function and Myringoplasty/Tympanoplasty
An observational study of Tympanic Membrane Perforation, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Eustachian tube function testing
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 2 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing myringoplasty/tympanoplasty for eardrum perforation after a tube or after a retained tube is removed.
Who may be able to join
- 3-16 years old
- being scheduled for myringoplasty/tympanoplasty with removal of a patent tube or for repair of existing eardrum perforation remaining after a tube
- less than or equal to 8 weeks prior to surgery
Who cannot join
- syndromic or with craniofacial malformation (eg, Down syndrome, cleft palate)
- parent anticipates being unable to keep appointments (e.g., moving out of area)
- child unable to tolerate testing
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Research Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome
This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. When a person goes up in an airplane and their ears "pop" or when one yawns and their ears "pop", that is the Eustachian tube opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as in the environment and keeping the middle ear free of fluid. It is thought that in children with middle-ear disease, the muscles that open the Eustachian tube do not work very well; this seems to get better in many children as they get older. It is thought that poor Eustachian tube function is the cause of failures when holes in the eardrum are patched and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see whether it can be predicted, based on testing Eustachian tube function before surgery, whether patching the eardrum will be successful and whether fluid will come back in the ear after it is patched.
Read the detailed description
This study involves 1 visit to Children's Hospital of Pittsburgh of UPMC for Eustachian tube function testing and 2 visits, at approximately 6 months and at 12 months, after surgery to examine the ears.
Entry (Visit 1; approximately 40-60 minutes) At the entry visit, the child's medical history will be reviewed to ensure he/she is eligible for the study. The parent will be asked questions about their family, including family size, pets, medical history, tobacco smoke exposure, education and occupation, and living conditions. They will also be asked questions about their child, regarding such things as breastfeeding, daycare, tobacco smoke exposure and allergies, and a detailed history of middle-ear disease will be recorded. The child will have an examination of the ears, nose and throat.
Tympanometry will be done, which can help to tell whether there is fluid in the middle ear and whether there is an opening/hole in the eardrum. This is a common office procedure and is done by inserting a small probe (a rubber or plastic tube that measures ear pressure) half way into the ear canal and changing the pressure in the probe. That pressure change is small, can be felt but is rarely associated with any discomfort.
The function of the child's Eustachian tube on the side of the eardrum that is going to be patched will be tested. A small ear plug will be sealed partway into the child's ear canal. This plug is attached to a machine that can change the pressure in the ear and measure the pressure at which the Eustachian tube opens and closes, as well as the ease of airflow through the Eustachian tube and the ability to open the Eustachian tube during swallowing. The tests only require that the child not pull the ear plug from his/her ear and perform certain (age-appropriate) procedures designed to open his/her Eustachian tube such as swallowing with an open and pinched nose, blowing against a closed nose and deep breathing. The total time for testing is about 20 minutes and this period is broken into times of rest and times of tests. If the child has holes in both eardrums that are going to be repaired, testing may take 40 minutes.
After the entry testing: The child's ear surgeon will take a picture of the eardrum at the time of surgery to document the size of the hole. If the child does not require another surgical procedure after the surgery to close the eardrum because of failure of the hole to close or recurrence of ear problems such as infection or fluid in the ear, the child will have study visits for examination of the ears, nose and throat as well as tympanometry at approximately 6 months and 12 months after surgery. If he or she is being seen by the ear surgeon around these times, the study visit and their clinic visit can be done at the same time.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Eustachian tube function testing
- Keywords
- perforation, tympanoplasty, myringoplasty, Eustachian tube function, tympanostomy tube
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eustachian tube function testingOther
Eustachian tube function testing will consist of some or all of the following tests: Inflation/Deflation test, Forced Response test, Compliance test,Valsalva, Toynbee and Sniffing
| Study group | Role | What they receive |
|---|---|---|
| children undergoing myringoplasty/tympanoplasty | child having repair of eardrum because of hole in eardrum after tube extruded or after tube removal Receives: Other: Eustachian tube function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of perforation
Evidence of intact eardrum at 12 months after surgery
Measured: 12 months
Recurrence of otitis media
Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months
Measured: by 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startNov 2012
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Pediatric Otolaryngology
- Responsible party
- Principal investigator, Margaretha L. Casselbrant, University of Pittsburgh
- Investigators
- Margaretha L Casselbrant, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766856
- Sponsor's protocol ID
- PRO12040564
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eustachian Tube Function as a Predictor of Myringoplasty/Tympanoplasty Outcome
- ClinicalTrials.gov ID
- NCT01766856
- Acronym / sponsor ID
- PRO12040564
- Conditions
- Tympanic Membrane Perforation
- Keywords
- perforation, tympanoplasty, myringoplasty, Eustachian tube function, tympanostomy tube
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Department of Pediatric Otolaryngology
- Study start
- Nov 2012
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. When a person goes up in an airplane and their ears "pop" or when one yawns and their ears "pop", that is the Eustachian tube opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as in the environment and keeping the middle ear free of fluid. It is thought that in children with middle-ear disease, the muscles that open the Eustachian tube do not work very well; this seems to get better in many children as they get older. It is thought that poor Eustachian tube function is the cause of failures when holes in the eardrum are patched and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see whether it can be predicted, based on testing Eustachian tube function before surgery, whether patching the eardrum will be successful and whether fluid will come back in the ear after it is patched.
Detailed description
This study involves 1 visit to Children's Hospital of Pittsburgh of UPMC for Eustachian tube function testing and 2 visits, at approximately 6 months and at 12 months, after surgery to examine the ears.
Entry (Visit 1; approximately 40-60 minutes) At the entry visit, the child's medical history will be reviewed to ensure he/she is eligible for the study. The parent will be asked questions about their family, including family size, pets, medical history, tobacco smoke exposure, education and occupation, and living conditions. They will also be asked questions about their child, regarding such things as breastfeeding, daycare, tobacco smoke exposure and allergies, and a detailed history of middle-ear disease will be recorded. The child will have an examination of the ears, nose and throat.
Tympanometry will be done, which can help to tell whether there is fluid in the middle ear and whether there is an opening/hole in the eardrum. This is a common office procedure and is done by inserting a small probe (a rubber or plastic tube that measures ear pressure) half way into the ear canal and changing the pressure in the probe. That pressure change is small, can be felt but is rarely associated with any discomfort.
The function of the child's Eustachian tube on the side of the eardrum that is going to be patched will be tested. A small ear plug will be sealed partway into the child's ear canal. This plug is attached to a machine that can change the pressure in the ear and measure the pressure at which the Eustachian tube opens and closes, as well as the ease of airflow through the Eustachian tube and the ability to open the Eustachian tube during swallowing. The tests only require that the child not pull the ear plug from his/her ear and perform certain (age-appropriate) procedures designed to open his/her Eustachian tube such as swallowing with an open and pinched nose, blowing against a closed nose and deep breathing. The total time for testing is about 20 minutes and this period is broken into times of rest and times of tests. If the child has holes in both eardrums that are going to be repaired, testing may take 40 minutes.
After the entry testing: The child's ear surgeon will take a picture of the eardrum at the time of surgery to document the size of the hole. If the child does not require another surgical procedure after the surgery to close the eardrum because of failure of the hole to close or recurrence of ear problems such as infection or fluid in the ear, the child will have study visits for examination of the ears, nose and throat as well as tympanometry at approximately 6 months and 12 months after surgery. If he or she is being seen by the ear surgeon around these times, the study visit and their clinic visit can be done at the same time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children undergoing myringoplasty/tympanoplasty | – | Other: Eustachian tube function testingchild having repair of eardrum because of hole in eardrum after tube extruded or after tube removal |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing myringoplasty/tympanoplasty for eardrum perforation after a tube or after a retained tube is removed.
Key inclusion criteria (3 listed)
- 3-16 years old
- being scheduled for myringoplasty/tympanoplasty with removal of a patent tube or for repair of existing eardrum perforation remaining after a tube
- less than or equal to 8 weeks prior to surgery
Key exclusion criteria (3 listed)
- syndromic or with craniofacial malformation (eg, Down syndrome, cleft palate)
- parent anticipates being unable to keep appointments (e.g., moving out of area)
- child unable to tolerate testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eustachian tube function testingEustachian tube function testing will consist of some or all of the following tests: Inflation/Deflation test, Forced Response test, Compliance test,Valsalva, Toynbee and Sniffing | Other | children undergoing myringoplasty/tympanoplasty |
Primary outcome
Healing of perforation
Time frame: 12 months
Evidence of intact eardrum at 12 months after surgery
Recurrence of otitis media
Time frame: by 12 months
Recurrence of otitis media (acute otitis media and/or otitis media with effusion) by 12 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaretha L Casselbrant, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanic Membrane Perforation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of perforation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.