Children, OnlyNCT04256590
Tongue Depressor-related Tongue Swelling
An observational study of Children, Only and Adenoidal Hypertrophy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Children, Only, Adenoidal Hypertrophy, Adenoid Disease - Chronic
- What is being tested?
- Ultrasonography imaging
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Mar 2019
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic adenoiditis and adenoid hypertrophy (except tonsillectomy surgeries) and were to undergo adenoidectomy surgery.
Who may be able to join
- Patients aged 16 years or younger
- Undergo adenoidectomy surgery
- Patients informed consent obtained from the parents
- Patients aged 16 years or younger
- Patients who did not need adenoidectomy surgery and any head and neck procedures
- Patients who underwent endotracheal intubation under general anesthesia except adenoidectomy and head and neck surgery.
Who cannot join
- Patients aged older than 16 years
- Patients with a history of syndromal craniofacial abnormalities
- Patients with systemic disorders and other otolaryngologic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tongue Depressor-related Tongue Swelling in Adenoidectomy Surgeries in Pediatric Patients
This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.
Read the detailed description
The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.
- Conditions
- Children, Only, Adenoidal Hypertrophy, Adenoid Disease - Chronic, Complication, Side Effect
- Being tested
- Ultrasonography imaging
- Keywords
- children, tongue disease, ultrasonography, enlarge tongue, adenoid
- Medical subject headings
- Tongue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography imagingDiagnostic test
This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.
| Study group | Role | What they receive |
|---|---|---|
| Study | Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Tongue surface areas were measured twice by submental USG.The first measurements (TSA2) were done immediately after endotracheal intubation but before insertion and placement of the tongue depressor. The second measurements (TSA1) were done after adenoidectomy surgery and after removal of the tongue depressor but just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue swelling. Receives: Diagnostic Test: Ultrasonography imaging | |
| Control | This group included patients aged 16 years or younger who did not need adenoidectomy surgery and any head and neck procedures. Tongue surface areas of the patients were measured twice by submental USG as in the study group. TSA1s were done immediately after endotracheal intubation, and TSA2s were done at the end of the surgical procedure just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue edema. Receives: Diagnostic Test: Ultrasonography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging.
This study aimed to evaluate the change from baseline in tongue surface area on the ultrasonography imaging due to the tongue depressor.
Measured: 2018-2019 (6 months)
Secondary outcomes (1)
Detection of swelling formation in tongue by using ultrasonography imaging.
This study aimed to measure and detect the tongue swelling by using ultrasonography imaging due to the tongue depressor.
Measured: 2018-2019 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Sep 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- More trials run by Selcuk 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-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Onal, Selcuk University
- Investigators
- Merih Onal, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256590
- Sponsor's protocol ID
- 2018/18
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Depressor-related Tongue Swelling in Adenoidectomy Surgeries in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04256590
- Acronym / sponsor ID
- 2018/18
- Conditions
- Children, Only, Adenoidal Hypertrophy, Adenoid Disease - Chronic, Complication, Side Effect
- Keywords
- children, tongue disease, ultrasonography, enlarge tongue, adenoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Feb 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.
This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.
Detailed description
The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Ultrasonography imagingPatients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Tongue surface areas were measured twice by submental USG.The first measurements (TSA2) were done immediately after endotracheal intubation but before insertion and placement of the tongue depressor. The second measurements (TSA1) were done after adenoidectomy surgery and after removal of the tongue depressor but just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue swelling. |
| Control | – | Diagnostic Test: Ultrasonography imagingThis group included patients aged 16 years or younger who did not need adenoidectomy surgery and any head and neck procedures. Tongue surface areas of the patients were measured twice by submental USG as in the study group. TSA1s were done immediately after endotracheal intubation, and TSA2s were done at the end of the surgical procedure just before extubation. The difference between TSA2 and TSA1 (i.e., (TSA2-TSA1) was used to defined the occurrence of tongue edema. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic adenoiditis and adenoid hypertrophy (except tonsillectomy surgeries) and were to undergo adenoidectomy surgery.
Key inclusion criteria (6 listed)
- Patients aged 16 years or younger
- Undergo adenoidectomy surgery
- Patients informed consent obtained from the parents
- Patients aged 16 years or younger
- Patients who did not need adenoidectomy surgery and any head and neck procedures
Key exclusion criteria (3 listed)
- Patients aged older than 16 years
- Patients with a history of syndromal craniofacial abnormalities
- Patients with systemic disorders and other otolaryngologic problems
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 |
|---|---|---|
| Ultrasonography imagingThis study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas. | Diagnostic test | Control, Study |
Primary outcome
Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging.
Time frame: 2018-2019 (6 months)
This study aimed to evaluate the change from baseline in tongue surface area on the ultrasonography imaging due to the tongue depressor.
1 secondary outcome
Detection of swelling formation in tongue by using ultrasonography imaging.
Time frame: 2018-2019 (6 months)
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 5 Feb 2020.
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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.
Merih Onal principal investigator
Selcuk University
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 Children, Only and Adenoidal Hypertrophy, run by Selcuk 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 6 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: finished, as of the sponsor's last update on 5 Feb 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?
Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging. (time frame: 2018-2019 (6 months)). 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 5 Feb 2020.