Pediatric AnesthesiaNCT07384611
Preoperative Prediction of Difficult Airway in Children
An observational study of Pediatric Anesthesia and Difficult Laryngoscopy, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the predictive value of preoperative clinical airway assessment parameters for difficult airway management in pediatric patients undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Pediatric Anesthesia, Difficult Laryngoscopy
- What is being tested?
- Preoperative Clinical Airway Assessment
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 20 May 2027
- 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 1 day to 12 years
- All sexes
- Child
Study population: The study population consists of pediatric patients aged 0 to 12 years who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Who may be able to join
- Pediatric patients aged 0-12 years
- Scheduled for elective surgery requiring endotracheal intubation under general anesthesia
- ASA physical status I-III
- Written informed consent obtained from parent(s) or legal guardian(s)
Who cannot join
- Patients older than 12 years
- ASA physical status IV or higher
- Emergency situations that do not allow systematic documentation of the airway management process
- Presence of a congenital or acquired tracheostomy
- Surgical procedures planned to be performed using a supraglottic airway without endotracheal intubation
- Surgical procedures planned to be performed using face mask ventilation without endotracheal intubation
- Inability to obtain parental or legal guardian consent
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, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06000
Elif Şule Özdemir Sezgi, M.D., 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, Professor, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: Prediction of Difficult Airway in Pediatric Patients Using Preoperative Clinical Parameters
This prospective observational study aims to evaluate the predictive value of preoperative clinical airway assessment parameters for difficult airway management in pediatric patients undergoing elective surgery under general anesthesia. Preoperative clinical measurements and bedside airway tests will be recorded, and their association with intraoperative airway outcomes, including difficult laryngoscopy and difficult intubation, will be analyzed. Difficult laryngoscopy will be defined as Cormack-Lehane grade III-IV, while secondary outcomes will include difficult intubation, difficult mask ventilation, and airway-related complications. The study seeks to identify clinically applicable predictors and improve preoperative risk stratification for pediatric airway management. The findings may contribute to safer anesthetic practice in children by facilitating early identification of patients at increased airway risk.
- Conditions
- Pediatric Anesthesia, Difficult Laryngoscopy
- Being tested
- Preoperative Clinical Airway Assessment
- Keywords
- Pediatric Anesthesia, Difficult Laryngoscopy, Difficult Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Clinical Airway AssessmentOther
Preoperative clinical airway assessment including bedside airway examination and anthropometric measurements performed as part of routine anesthetic evaluation, without any additional intervention beyond standard clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult Laryngoscopy
Difficult laryngoscopy defined as Cormack-Lehane grade III or IV during laryngoscopy at tracheal intubation.
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
First-Attempt Intubation Success
Successful tracheal intubation achieved on the first attempt without the need for additional airway devices or techniques.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start2 Feb 2026
- Primary completion3 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384611
- Sponsor's protocol ID
- AEŞH-EK-2026-009
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 11 Feb 2026
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Difficult Airway in Pediatric Patients Using Preoperative Clinical Parameters
- ClinicalTrials.gov ID
- NCT07384611
- Acronym / sponsor ID
- AEŞH-EK-2026-009
- Conditions
- Pediatric Anesthesia, Difficult Laryngoscopy
- Keywords
- Pediatric Anesthesia, Difficult Laryngoscopy, Difficult Airway
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 3 Feb 2026 (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 prospective observational study aims to evaluate the predictive value of preoperative clinical airway assessment parameters for difficult airway management in pediatric patients undergoing elective surgery under general anesthesia. Preoperative clinical measurements and bedside airway tests will be recorded, and their association with intraoperative airway outcomes, including difficult laryngoscopy and difficult intubation, will be analyzed. Difficult laryngoscopy will be defined as Cormack-Lehane grade III-IV, while secondary outcomes will include difficult intubation, difficult mask ventilation, and airway-related complications. The study seeks to identify clinically applicable predictors and improve preoperative risk stratification for pediatric airway management. The findings may contribute to safer anesthetic practice in children by facilitating early identification of patients at increased airway risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population consists of pediatric patients aged 0 to 12 years who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Key inclusion criteria (4 listed)
- Pediatric patients aged 0-12 years
- Scheduled for elective surgery requiring endotracheal intubation under general anesthesia
- ASA physical status I-III
- Written informed consent obtained from parent(s) or legal guardian(s)
Key exclusion criteria (7 listed)
- Patients older than 12 years
- ASA physical status IV or higher
- Emergency situations that do not allow systematic documentation of the airway management process
- Presence of a congenital or acquired tracheostomy
- Surgical procedures planned to be performed using a supraglottic airway without endotracheal intubation
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 |
|---|---|---|
| Preoperative Clinical Airway AssessmentPreoperative clinical airway assessment including bedside airway examination and anthropometric measurements performed as part of routine anesthetic evaluation, without any additional intervention beyond standard clinical practice. | Other | – |
Primary outcome
Difficult Laryngoscopy
Time frame: Perioperative/Periprocedural
Difficult laryngoscopy defined as Cormack-Lehane grade III or IV during laryngoscopy at tracheal intubation.
1 secondary outcome
First-Attempt Intubation Success
Time frame: Perioperative/Periprocedural
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 11 Feb 2026.
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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.
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 Pediatric Anesthesia and Difficult Laryngoscopy, run by Diskapi Yildirim Beyazit Education and Research 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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 Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult Laryngoscopy (time frame: Perioperative/Periprocedural). 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 11 Feb 2026.