Obstructive Tonsillar HypertrophyNCT04380272
Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography
An observational study of Obstructive Tonsillar Hypertrophy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Chronic tonsillar hypertrophy is one of the most common causes of upper airway obstruction in children. Currently, several clinical staging systems are used to evaluate airway obstruction due to tonsillar hypertrophy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Obstructive Tonsillar Hypertrophy
- What is being tested?
- The ROC analysis
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Feb 2020
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The pediatric patients who presented to the otorhinolaryngology outpatient clinic with complaints of recurrent tonsillitis, snoring, and/or witnessed apnea between January 2019 and December 2019.
Who may be able to join
- The pediatric patients
Who cannot join
- Adult patients
- Patients identified with active infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography (Pamukkale Technique)
Chronic tonsillar hypertrophy is one of the most common causes of upper airway obstruction in children. Currently, several clinical staging systems are used to evaluate airway obstruction due to tonsillar hypertrophy. However, as these staging systems are based on a physical examination, it is not always possible to accurately evaluate the tonsil size, especially in children, and so objective and reliable methods are required in this field. In this study, the investigators aimed to develop a new method for the objective evaluation of airway obstruction due to tonsillar hypertrophy using submental ultrasonography (US) in children.
Read the detailed description
Tonsillectomy is one of the most frequently performed operations in childhood, and one of the most important indications of this surgery is chronic tonsillar hypertrophy. Chronic tonsillar hypertrophy accounts for 80% of cases with obstructive sleep apnea syndrome (OSAS) in childhood, and growth and development delay, low academic performance, facial developmental abnormalities, and cardiopulmonary diseases may emerge as a result. For this reason, an accurate evaluation of tonsil size is crucial both during clinical follow-up and in tonsillectomy decisions.
Currently, several clinical staging systems are used to evaluate tonsil size in children, with the "Brodsky" and "Friedman" scales being the most commonly used systems. These staging systems make use of a physical examination, with tonsil hypertrophies generally classified into 4 stages based on the extension of the tonsil from the anterior plica to the midline. Stages 3 and 4 tonsil hypertrophy are generally accepted as obstructive, and a tonsillectomy decision is made when clinical complaints support this. For such an evaluation of tonsil grade, the child should be cooperative, should easily open his/her mouth, and should not gag. In the event of the patient's non-compliance, the size of the tongue and tongue base, the hyperactive gag reflex, and trismus may challenge this evaluation. The gag reflex during the examination causes the tonsils to move towards the midline, making the tonsils seem bigger than the real size. An obstruction at the hypopharyngeal level due to hypertrophic tonsils may be missed due to poor visualization of the inferior pole of the tonsil in patients with a large tongue. For these reasons, a correct clinical evaluation of the tonsil size may not always be possible through a physical examination. Thus objective and reliable methods are required for the classification of tonsillar hypertrophy.
There have been no studies to date investigating the use of ultrasonography (US) in the evaluation of airway obstruction due to tonsillar hypertrophy, despite the advantages of high patient compliance, low cost, and no radiation exposure. The present study suggests a new method for the evaluation of airway obstruction due to tonsillar hypertrophy using the submental US in children.
- Conditions
- Obstructive Tonsillar Hypertrophy
- Being tested
- The ROC analysis
- Keywords
- tonsil, tonsillar hypertrophy, ultrasonography, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ROC analysisDiagnostic test
The Brodsky clinical stage and ultrasonographic data of the participants will be matched, and the diagnostic value of the submental US in the classification of tonsil hypertrophy as non-obstructive and obstructive will be evaluated. A ROC analysis will be used to determine the optimal cut-off value.
| Study group | Role | What they receive |
|---|---|---|
| Brodsky tonsil staging system | An oropharynx examination of all participants will be performed and tonsil size will be evaluated according to the Brodsky staging system. According to this staging system, tonsil sizes will be classified as stage I when the tonsils fill less than 25% of the transverse oropharyngeal space measured between the anterior tonsillar pillars; stage II when they fill between 25% and 50%, stage III when they fill between 50% and 75%, and stage IV when they fill more than 75%. | |
| The ultrasonographic data | The submental ultrasonography will be performed on all participants. Ultrasonographic examinations will be performed blinded to the physical examination results. All measurements will be performed by the same radiologist with experience in the field of ultrasonography. A GE LOGIQ E9 (GE Healthcare, Milwaukee, WI, USA) device will be used in the ultrasonography examination. The participants will be viewed using a 2-9 MHz linear probe from the submental region. The examination will be performed while the patient was lying in a supine position with a support placed under the neck. Receives: Diagnostic Test: The ROC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of tonsil size according to the Brodsky tonsil staging system
The investigators will classify the Brodsky Stage I and II cases as non-obstructive tonsillar hypertrophy and the Brodsky stage III and IV as obstructive tonsillar hypertrophy.
Measured: 20 minutes
The ultrasonographic intertonsillar distance, transverse length of the tongue base and the ratio of intertonsillar distance/transverse length of the tongue base
After the neck of the participant will be brought to extension, the ultrasound probe will be placed on the submental region, and both tonsils will be visualized in the midline in the transverse plane. The narrowest airway space will be marked between the two tonsils and the intertonsillar distance (ITD) will be measured. Subsequently, in the same region, the attachments of the palatoglossal muscles to the tongue base, as the projection of the anterior plicae, will be determined, and the widest transverse length of the tongue base (TLTB) at this level will be measured. The ratio of ITD to TLTB will be calculated for each participant.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Tonsillar HypertrophyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem Mengi, Pamukkale University
- Investigators
- Erdem Mengi, Principal investigator, Pamukkale Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380272
- Sponsor's protocol ID
- 60116787-020/81401
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography (Pamukkale Technique)
- ClinicalTrials.gov ID
- NCT04380272
- Acronym / sponsor ID
- 60116787-020/81401
- Conditions
- Obstructive Tonsillar Hypertrophy
- Keywords
- tonsil, tonsillar hypertrophy, ultrasonography, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 May 2020 (actual)
- 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.
Chronic tonsillar hypertrophy is one of the most common causes of upper airway obstruction in children. Currently, several clinical staging systems are used to evaluate airway obstruction due to tonsillar hypertrophy. However, as these staging systems are based on a physical examination, it is not always possible to accurately evaluate the tonsil size, especially in children, and so objective and reliable methods are required in this field. In this study, the investigators aimed to develop a new method for the objective evaluation of airway obstruction due to tonsillar hypertrophy using submental ultrasonography (US) in children.
Detailed description
Tonsillectomy is one of the most frequently performed operations in childhood, and one of the most important indications of this surgery is chronic tonsillar hypertrophy. Chronic tonsillar hypertrophy accounts for 80% of cases with obstructive sleep apnea syndrome (OSAS) in childhood, and growth and development delay, low academic performance, facial developmental abnormalities, and cardiopulmonary diseases may emerge as a result. For this reason, an accurate evaluation of tonsil size is crucial both during clinical follow-up and in tonsillectomy decisions.
Currently, several clinical staging systems are used to evaluate tonsil size in children, with the "Brodsky" and "Friedman" scales being the most commonly used systems. These staging systems make use of a physical examination, with tonsil hypertrophies generally classified into 4 stages based on the extension of the tonsil from the anterior plica to the midline. Stages 3 and 4 tonsil hypertrophy are generally accepted as obstructive, and a tonsillectomy decision is made when clinical complaints support this. For such an evaluation of tonsil grade, the child should be cooperative, should easily open his/her mouth, and should not gag. In the event of the patient's non-compliance, the size of the tongue and tongue base, the hyperactive gag reflex, and trismus may challenge this evaluation. The gag reflex during the examination causes the tonsils to move towards the midline, making the tonsils seem bigger than the real size. An obstruction at the hypopharyngeal level due to hypertrophic tonsils may be missed due to poor visualization of the inferior pole of the tonsil in patients with a large tongue. For these reasons, a correct clinical evaluation of the tonsil size may not always be possible through a physical examination. Thus objective and reliable methods are required for the classification of tonsillar hypertrophy.
There have been no studies to date investigating the use of ultrasonography (US) in the evaluation of airway obstruction due to tonsillar hypertrophy, despite the advantages of high patient compliance, low cost, and no radiation exposure. The present study suggests a new method for the evaluation of airway obstruction due to tonsillar hypertrophy using the submental US in children.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brodsky tonsil staging system | – | –An oropharynx examination of all participants will be performed and tonsil size will be evaluated according to the Brodsky staging system. According to this staging system, tonsil sizes will be classified as stage I when the tonsils fill less than 25% of the transverse oropharyngeal space measured between the anterior tonsillar pillars; stage II when they fill between 25% and 50%, stage III when they fill between 50% and 75%, and stage IV when they fill more than 75%. |
| The ultrasonographic data | – | Diagnostic Test: The ROC analysisThe submental ultrasonography will be performed on all participants. Ultrasonographic examinations will be performed blinded to the physical examination results. All measurements will be performed by the same radiologist with experience in the field of ultrasonography. A GE LOGIQ E9 (GE Healthcare, Milwaukee, WI, USA) device will be used in the ultrasonography examination. The participants will be viewed using a 2-9 MHz linear probe from the submental region. The examination will be performed while the patient was lying in a supine position with a support placed under the neck. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The pediatric patients who presented to the otorhinolaryngology outpatient clinic with complaints of recurrent tonsillitis, snoring, and/or witnessed apnea between January 2019 and December 2019.
Key inclusion criteria (1 listed)
- The pediatric patients
Key exclusion criteria (2 listed)
- Adult patients
- Patients identified with active infections
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 |
|---|---|---|
| The ROC analysisThe Brodsky clinical stage and ultrasonographic data of the participants will be matched, and the diagnostic value of the submental US in the classification of tonsil hypertrophy as non-obstructive and obstructive will be evaluated. A ROC analysis will be used to determine the optimal cut-off value. | Diagnostic test | The ultrasonographic data |
Primary outcome
The evaluation of tonsil size according to the Brodsky tonsil staging system
Time frame: 20 minutes
The investigators will classify the Brodsky Stage I and II cases as non-obstructive tonsillar hypertrophy and the Brodsky stage III and IV as obstructive tonsillar hypertrophy.
The ultrasonographic intertonsillar distance, transverse length of the tongue base and the ratio of intertonsillar distance/transverse length of the tongue base
Time frame: 20 minutes
After the neck of the participant will be brought to extension, the ultrasound probe will be placed on the submental region, and both tonsils will be visualized in the midline in the transverse plane. The narrowest airway space will be marked between the two tonsils and the intertonsillar distance (ITD) will be measured. Subsequently, in the same region, the attachments of the palatoglossal muscles to the tongue base, as the projection of the anterior plicae, will be determined, and the widest transverse length of the tongue base (TLTB) at this level will be measured. The ratio of ITD to TLTB will be calculated for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Individual participant dataSharing planned: No
Related trials for Obstructive Tonsillar Hypertrophy
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Sleep Apnea, Obstructives, Tonsil Hypertrophy
Recruiting
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children
Not yet recruiting
Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea
Obstructive Sleep Apnea, Tonsillar Hypertrophy
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.
Erdem Mengi principal investigator
Pamukkale Üniversitesi Tıp Fakültesi
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 Obstructive Tonsillar Hypertrophy, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 May 2020. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The evaluation of tonsil size according to the Brodsky tonsil staging system (time frame: 20 minutes). 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 8 May 2020.