Adenotonsillectomy SurgeryNCT07057661
Evaluation of Difficult Airway With Ultrasound
An observational study of Adenotonsillectomy Surgery, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
An unexpected difficult airway can lead to severe hypoxia and even death. Accurate airway assessment can reduce the incidence of difficult endotracheal intubation and related complications. Studies have shown that some ultrasonic indicators can predict difficult airways in adults to some extent. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Adenotonsillectomy Surgery
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who underwent adenotonsillectomy and any surgical operation
Who may be able to join
- ASA 1-2 patients
- Pediatric patients aged 3-8
- Those planned for elective surgery
Who cannot join
- Those with a history of congenital anomalies (head, face, body)
- ASA 3-4-5 patients
- Those who will undergo emergency surgery
- Those who will be subjected to an airway or anesthesia technique other than orotracheal intubation
- Newborn group patients
- Patients younger than 3 years old and older than 8 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İzmir City Hospital
Izmir, Bayraklı
05053428504, drtuba2004@hotmail.com
About this study
Official title: Evaluation of Difficult Airway in Adenotonsillectomy Patients With Ultrasound
An unexpected difficult airway can lead to severe hypoxia and even death. Accurate airway assessment can reduce the incidence of difficult endotracheal intubation and related complications. Studies have shown that some ultrasonic indicators can predict difficult airways in adults to some extent. Studies have begun to investigate whether ultrasonic parameters can be used to predict difficult airways in children.Ultrasonic measurements of certain airway parameters have predictive value for difficult airways; therefore, airway ultrasonography is recommended as an aid in difficult airway prediction. We think that in pediatric patients with adenotonsillectomy, we will encounter more difficult airway because there may be anatomical differentiation due to adenoid and tonsillar hypertrophy. We aimed to evaluate the frequency of difficult airway with USG measurements in pediatric patients undergoing adenotonsillectomy.
Group 1:Pediatric patients who underwent adenotonsillectomy Group 2: Pediatric patients who underwent any surgical operation We will evaluate two patient groups.
Read the detailed description
Ultrasonography (USG) is widely used in airway management, such as prediction of difficult airways, localization of cricothyroid membranes, selection of tracheal tubes, and evaluation of patients with a full stomach. Among these, ultrasonic measurements of the dimensions of certain airway parameters have predictive value for difficult airways; therefore, airway ultrasonography is recommended as an aid in difficult airway prediction. Many studies have shown that some ultrasonic parameters such as hyomental distance in the extension position and distance from the skin to the epiglottis can predict difficult airways in adults. However, it is unclear whether these parameters can be used to predict difficult airways in children. In recent studies, various protocols have started to be established . We think that we will encounter more difficult airways in pediatric patients with adenotonsillectomy because there may be anatomical differentiation due to adenoid and tonsillar hypertrophy. Therefore, we will evaluate the relationship between skin-epiglottic distance, hyomental distance and tongue base thickness measurements, which are used in most studies, and the mallampati score on physical examination and the Cormack Lehane score during laryngoscopy. The aim of this study was to compare the frequency of difficult airway between pediatric patients who underwent adenotonsillectomy (Group 1) and pediatric patients who underwent any surgical operation (Group 2) using USG measurements.
Group 1:Pediatric patients who underwent adenotonsillectomy Group 2: Pediatric patients who underwent any surgical operation
- Conditions
- Adenotonsillectomy Surgery
- Keywords
- airway management, pediatric patients, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pediatric patients who underwent adenotonsillectomy | Not described | |
| Group 2: Pediatric patients who underwent any surgical operation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSE: Distance from skin to epiglottis
the vertical distances from the submental skin to the midpoint of the epiglottis
Measured: Preoperative , before the administration of anesthesia
HMDE: Hyomental distance in the extended position
the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone
Measured: Preoperative , before the administration of anesthesia
Tongue base thickness
Measured: Preoperative , before the administration of anesthesia
Secondary outcomes (1)
Cormark Lehane score
Grade 1: being a full view of the glottis Grade 2 : being a partial view Grade 3: being only a view of the epiglottis Grade 4: being an absent view of the glottis and epiglottis
Measured: During laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenotonsillectomy SurgeryStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuba Kuvvet Yoldaş, Izmir City Hospital
- Investigators
- Tuba Kuvvet Yoldas, MD, Anesthesiology Specialist, Principal investigator, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057661
- Sponsor's protocol ID
- İSH-ANS-TK-02
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Difficult Airway in Adenotonsillectomy Patients With Ultrasound
- ClinicalTrials.gov ID
- NCT07057661
- Acronym / sponsor ID
- İSH-ANS-TK-02
- Conditions
- Adenotonsillectomy Surgery
- Keywords
- airway management, pediatric patients, ultrasonography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Jul 2025 (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.
An unexpected difficult airway can lead to severe hypoxia and even death. Accurate airway assessment can reduce the incidence of difficult endotracheal intubation and related complications. Studies have shown that some ultrasonic indicators can predict difficult airways in adults to some extent. Studies have begun to investigate whether ultrasonic parameters can be used to predict difficult airways in children.Ultrasonic measurements of certain airway parameters have predictive value for difficult airways; therefore, airway ultrasonography is recommended as an aid in difficult airway prediction. We think that in pediatric patients with adenotonsillectomy, we will encounter more difficult airway because there may be anatomical differentiation due to adenoid and tonsillar hypertrophy. We aimed to evaluate the frequency of difficult airway with USG measurements in pediatric patients undergoing adenotonsillectomy.
Group 1:Pediatric patients who underwent adenotonsillectomy Group 2: Pediatric patients who underwent any surgical operation We will evaluate two patient groups.
Detailed description
Ultrasonography (USG) is widely used in airway management, such as prediction of difficult airways, localization of cricothyroid membranes, selection of tracheal tubes, and evaluation of patients with a full stomach. Among these, ultrasonic measurements of the dimensions of certain airway parameters have predictive value for difficult airways; therefore, airway ultrasonography is recommended as an aid in difficult airway prediction. Many studies have shown that some ultrasonic parameters such as hyomental distance in the extension position and distance from the skin to the epiglottis can predict difficult airways in adults. However, it is unclear whether these parameters can be used to predict difficult airways in children. In recent studies, various protocols have started to be established . We think that we will encounter more difficult airways in pediatric patients with adenotonsillectomy because there may be anatomical differentiation due to adenoid and tonsillar hypertrophy. Therefore, we will evaluate the relationship between skin-epiglottic distance, hyomental distance and tongue base thickness measurements, which are used in most studies, and the mallampati score on physical examination and the Cormack Lehane score during laryngoscopy. The aim of this study was to compare the frequency of difficult airway between pediatric patients who underwent adenotonsillectomy (Group 1) and pediatric patients who underwent any surgical operation (Group 2) using USG measurements.
Group 1:Pediatric patients who underwent adenotonsillectomy Group 2: Pediatric patients who underwent any surgical operation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pediatric patients who underwent adenotonsillectomy | – | – |
| Group 2: Pediatric patients who underwent any surgical operation | – | – |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who underwent adenotonsillectomy and any surgical operation
Key inclusion criteria (3 listed)
- ASA 1-2 patients
- Pediatric patients aged 3-8
- Those planned for elective surgery
Key exclusion criteria (6 listed)
- Those with a history of congenital anomalies (head, face, body)
- ASA 3-4-5 patients
- Those who will undergo emergency surgery
- Those who will be subjected to an airway or anesthesia technique other than orotracheal intubation
- Newborn group patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DSE: Distance from skin to epiglottis
Time frame: Preoperative , before the administration of anesthesia
the vertical distances from the submental skin to the midpoint of the epiglottis
HMDE: Hyomental distance in the extended position
Time frame: Preoperative , before the administration of anesthesia
the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone
Tongue base thickness
Time frame: Preoperative , before the administration of anesthesia
1 secondary outcome
Cormark Lehane score
Time frame: During laryngoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- 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.
Tuba Kuvvet Yoldas, MD, Anesthesiology Specialist principal investigator
Izmir City Hospital
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 Adenotonsillectomy Surgery, run by Izmir City Hospital 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Kuvvet Yoldas, MD (+905053428504, tubayoldas2297@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSE: Distance from skin to epiglottis (time frame: Preoperative , before the administration of anesthesia). The study lists 3 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 20 Aug 2025.