Difficult AirwayNCT07694167
Airway Ultrasound and PeDiAC Score in Pediatric Patients
An observational study of Difficult Airway and Difficult Intubation, run by Samsun University.
Trial summary
This prospective observational study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score in pediatric patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Difficult Airway, Difficult Intubation, Airway Assessment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2026to 1 Jan 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of pediatric patients aged 1-18 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective surgical procedures requiring endotracheal intubation under general anesthesia at a tertiary care hospital. Eligible patients whose parents or legal guardians provide written informed consent and who meet all inclusion criteria will be consecutively enrolled during the study period.
Who may be able to join
- Children aged 1-18 years.
- Patients scheduled for elective surgery.
- Patients undergoing endotracheal intubation under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- Known craniofacial anomalies.
- Congenital airway malformations.
- Restricted cervical mobility.
- Emergency surgical procedures.
- Patients with a tracheostomy.
- Inability to obtain parental or legal guardian consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Relationship Between Ultrasonographic Airway Measurements and the PeDiAC Score in Pediatric Patients: A Prospective Observational Study
This prospective observational study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score in pediatric patients undergoing general anesthesia. The study will assess whether ultrasound-derived airway parameters are associated with difficult airway characteristics and PeDiAC scores.
Read the detailed description
Difficult airway management in pediatric patients remains a significant challenge for anesthesiologists and is associated with increased perioperative morbidity. Accurate preoperative identification of children at risk for difficult airway management is essential for improving patient safety and optimizing airway strategies.
Airway ultrasonography has emerged as a noninvasive and bedside imaging modality that allows detailed assessment of upper airway anatomy. Several ultrasonographic airway parameters have been investigated as potential predictors of difficult airway management in children. However, the predictive value of these measurements remains uncertain, and their relationship with standardized pediatric difficult airway assessment tools has not been fully established.
The Pediatric Difficult Airway Classification (PeDiAC) score is a recently developed tool designed to standardize the assessment of difficult airway characteristics in pediatric patients. Evaluating the association between ultrasonographic airway measurements and the PeDiAC score may improve preoperative airway assessment and facilitate the identification of children at increased risk of difficult airway management.
This prospective observational study aims to investigate the relationship between preoperative ultrasonographic airway measurements and the PeDiAC score in pediatric patients undergoing elective surgery under general anesthesia. Preoperative airway ultrasound measurements will be obtained and compared with PeDiAC scores recorded during airway management.
The primary objective is to evaluate the correlation between ultrasonographic airway measurements and the PeDiAC score. Secondary objectives include assessing the predictive value of ultrasonographic measurements for difficult airway management and identifying airway parameters associated with increased airway difficulty in pediatric patients.
- Conditions
- Difficult Airway, Difficult Intubation, Airway Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Ultrasonographic Airway Measurements and the PeDiAC Score
Assessment of the correlation between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score.
Measured: During airway assessment and endotracheal intubation
Secondary outcomes (3)
Predictive Value of Ultrasonographic Airway Measurements for Difficult Videolaryngoscopy
Evaluation of the predictive ability of preoperative ultrasonographic airway measurements for difficult videolaryngoscopy in pediatric patients.
Measured: During videolaryngoscopy
Relationship Between the PeDiAC Score and Cormack-Lehane Grade
Assessment of the association between the PeDiAC score and the Cormack-Lehane grade obtained during videolaryngoscopy.
Measured: During videolaryngoscopy
Relationship Between Intubation Time and Ultrasonographic Airway Measurements
Assessment of the association between intubation time and preoperative ultrasonographic airway measurements.
Measured: During endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start24 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694167
- Sponsor's protocol ID
- GOKAEK 2026/10/6
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Ultrasonographic Airway Measurements and the PeDiAC Score in Pediatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07694167
- Acronym / sponsor ID
- GOKAEK 2026/10/6
- Conditions
- Difficult Airway, Difficult Intubation, Airway Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 24 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Jul 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 relationship between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score in pediatric patients undergoing general anesthesia. The study will assess whether ultrasound-derived airway parameters are associated with difficult airway characteristics and PeDiAC scores.
Detailed description
Difficult airway management in pediatric patients remains a significant challenge for anesthesiologists and is associated with increased perioperative morbidity. Accurate preoperative identification of children at risk for difficult airway management is essential for improving patient safety and optimizing airway strategies.
Airway ultrasonography has emerged as a noninvasive and bedside imaging modality that allows detailed assessment of upper airway anatomy. Several ultrasonographic airway parameters have been investigated as potential predictors of difficult airway management in children. However, the predictive value of these measurements remains uncertain, and their relationship with standardized pediatric difficult airway assessment tools has not been fully established.
The Pediatric Difficult Airway Classification (PeDiAC) score is a recently developed tool designed to standardize the assessment of difficult airway characteristics in pediatric patients. Evaluating the association between ultrasonographic airway measurements and the PeDiAC score may improve preoperative airway assessment and facilitate the identification of children at increased risk of difficult airway management.
This prospective observational study aims to investigate the relationship between preoperative ultrasonographic airway measurements and the PeDiAC score in pediatric patients undergoing elective surgery under general anesthesia. Preoperative airway ultrasound measurements will be obtained and compared with PeDiAC scores recorded during airway management.
The primary objective is to evaluate the correlation between ultrasonographic airway measurements and the PeDiAC score. Secondary objectives include assessing the predictive value of ultrasonographic measurements for difficult airway management and identifying airway parameters associated with increased airway difficulty in pediatric patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of pediatric patients aged 1-18 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective surgical procedures requiring endotracheal intubation under general anesthesia at a tertiary care hospital. Eligible patients whose parents or legal guardians provide written informed consent and who meet all inclusion criteria will be consecutively enrolled during the study period.
Key inclusion criteria (4 listed)
- Children aged 1-18 years.
- Patients scheduled for elective surgery.
- Patients undergoing endotracheal intubation under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (6 listed)
- Known craniofacial anomalies.
- Congenital airway malformations.
- Restricted cervical mobility.
- Emergency surgical procedures.
- Patients with a tracheostomy.
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
Correlation Between Ultrasonographic Airway Measurements and the PeDiAC Score
Time frame: During airway assessment and endotracheal intubation
Assessment of the correlation between preoperative ultrasonographic airway measurements and the Pediatric Difficult Airway Classification (PeDiAC) score.
3 secondary outcomes
Predictive Value of Ultrasonographic Airway Measurements for Difficult Videolaryngoscopy
Time frame: During videolaryngoscopy
Relationship Between the PeDiAC Score and Cormack-Lehane Grade
Time frame: During videolaryngoscopy
Relationship Between Intubation Time and Ultrasonographic Airway Measurements
Time frame: During endotracheal intubation
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 9 Jul 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway and Difficult Intubation, run by Samsun University.
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 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hatice Selçuk Kuşderci (505 215 98 96, drkusderci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Ultrasonographic Airway Measurements and the PeDiAC Score (time frame: During airway assessment and endotracheal intubation). 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 Jul 2026.