Difficult IntubationUSG-AIRWAYNCT07343557
Ultrasound-Based Airway Assessment for Predicting Difficult Intubation in Adult Female Patients
An observational study of Difficult Intubation and Airway Assessment, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the ability of selected ultrasonographic airway measurements to predict difficult intubation in adult female patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Difficult Intubation, Airway Assessment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Dec 2025
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients aged 18-65 years undergoing elective surgery under general anesthesia at a tertiary care hospital. Participants were non-pregnant and scheduled for non-emergency procedures.
Who may be able to join
- Female patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III physical status I-III
- Scheduled for elective surgery under general anesthesia requiring tracheal intubation
- Ability to provide informed consent
Who cannot join
- Body mass index ≥30 kg/m²
- Known history of difficult intubation
- Anatomical airway abnormalities or head and neck pathology
- Pregnancy
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, Adana, 010650
About this study
Official title: Diagnostic Performance of Ultrasonographic Airway Measurements for Predicting Difficult Intubation in Adult Female Patients: A Prospective Observational Study
This prospective observational study aims to evaluate the ability of selected ultrasonographic airway measurements to predict difficult intubation in adult female patients undergoing elective surgery. Pre-induction airway ultrasonography will be performed to measure tongue thickness and anterior neck soft tissue-related parameters. These measurements will be compared with laryngoscopic findings during direct laryngoscopy. The results of this study may help identify practical and reliable ultrasound-based markers for preoperative airway assessment and improve patient safety.
Read the detailed description
This is a prospective, single-center observational study conducted in adult female patients scheduled for elective surgery under general anesthesia. The study was performed at the University of Health Sciences Adana City Training and Research Hospital after approval by the institutional ethics committee.
Before induction of anesthesia, standardized ultrasonographic airway assessments were performed by an experienced anesthesiologist. Measurements included tongue thickness, the distance from the skin to the anterior commissure of the vocal cords, the distance from the skin to the hyoid bone, and the distance from the skin to the epiglottis. All measurements were obtained under static pre-induction conditions using portable ultrasound equipment.
Following anesthesia induction, direct laryngoscopy was performed, and laryngoscopic view was graded according to the Cormack-Lehane classification. Difficult intubation was defined based on predefined laryngoscopic criteria. Ultrasonographic measurements were then analyzed for their diagnostic performance in predicting difficult intubation.
The primary objective of the study was to determine the most informative ultrasonographic parameter for predicting difficult intubation in this population. Secondary objectives included comparing the relative diagnostic value of different ultrasound measurements and evaluating their potential role in routine preoperative airway assessment.
- Conditions
- Difficult Intubation, Airway Assessment
- Keywords
- Airway Ultrasound, Tongue Thickness, Difficult Airway
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 |
|---|---|---|
| Airway Ultrasound Assessment Cohort | Adult female patients undergoing elective surgery in whom preoperative airway ultrasonography was performed for observational assessment of airway anatomy. No intervention was assigned as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Difficult Intubation
Difficult intubation defined as Cormack-Lehane grade III or IV and/or the need for additional airway devices or techniques during tracheal intubation.
Measured: Perioperative
Secondary outcomes (4)
Ultrasonographic Measurement of Tongue Thickness
Preoperative ultrasonographic measurement of tongue thickness performed in the suprahyoid region.
Measured: Preoperative assessment
Ultrasonographic Measurement of Skin-to-Hyoid Bone Distance
Preoperative ultrasonographic measurement of the distance between the skin and the hyoid bone.
Measured: Preoperative assessment
Ultrasonographic Measurement of Skin-to-Epiglottis Distance
Preoperative ultrasonographic measurement of the distance between the skin and the epiglottis.
Measured: Preoperative assessment
Ultrasonographic Measurement of Distance from Skin to Anterior Commissure of the Vocal Cords
Preoperative ultrasonographic measurement of the distance from the skin to the anterior commissure of the vocal cords.
Measured: Preoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 May 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur serkan Çitilcioğlu, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343557
- Sponsor's protocol ID
- ADN-USG-AIRWAY-2025
- Acronym
- USG-AIRWAY
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Citilcioglu US, Ozdogan HK, Yalim H, Atasever UB. Preoperative airway ultrasonography for predicting difficult intubation in adult female patients: a prospective observational study. BMC Anesthesiol. 2026 May 7;26(1):386. doi: 10.1186/s12871-026-03891-z.
PubMed 42098606
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Ultrasonographic Airway Measurements for Predicting Difficult Intubation in Adult Female Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07343557
- Acronym / sponsor ID
- USG-AIRWAY / ADN-USG-AIRWAY-2025
- Conditions
- Difficult Intubation, Airway Assessment
- Keywords
- Airway Ultrasound, Tongue Thickness, Difficult Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 15 Jan 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 ability of selected ultrasonographic airway measurements to predict difficult intubation in adult female patients undergoing elective surgery. Pre-induction airway ultrasonography will be performed to measure tongue thickness and anterior neck soft tissue-related parameters. These measurements will be compared with laryngoscopic findings during direct laryngoscopy. The results of this study may help identify practical and reliable ultrasound-based markers for preoperative airway assessment and improve patient safety.
Detailed description
This is a prospective, single-center observational study conducted in adult female patients scheduled for elective surgery under general anesthesia. The study was performed at the University of Health Sciences Adana City Training and Research Hospital after approval by the institutional ethics committee.
Before induction of anesthesia, standardized ultrasonographic airway assessments were performed by an experienced anesthesiologist. Measurements included tongue thickness, the distance from the skin to the anterior commissure of the vocal cords, the distance from the skin to the hyoid bone, and the distance from the skin to the epiglottis. All measurements were obtained under static pre-induction conditions using portable ultrasound equipment.
Following anesthesia induction, direct laryngoscopy was performed, and laryngoscopic view was graded according to the Cormack-Lehane classification. Difficult intubation was defined based on predefined laryngoscopic criteria. Ultrasonographic measurements were then analyzed for their diagnostic performance in predicting difficult intubation.
The primary objective of the study was to determine the most informative ultrasonographic parameter for predicting difficult intubation in this population. Secondary objectives included comparing the relative diagnostic value of different ultrasound measurements and evaluating their potential role in routine preoperative airway assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Ultrasound Assessment Cohort | – | –Adult female patients undergoing elective surgery in whom preoperative airway ultrasonography was performed for observational assessment of airway anatomy. No intervention was assigned as part of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients aged 18-65 years undergoing elective surgery under general anesthesia at a tertiary care hospital. Participants were non-pregnant and scheduled for non-emergency procedures.
Key inclusion criteria (4 listed)
- Female patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III physical status I-III
- Scheduled for elective surgery under general anesthesia requiring tracheal intubation
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Body mass index ≥30 kg/m²
- Known history of difficult intubation
- Anatomical airway abnormalities or head and neck pathology
- Pregnancy
- Emergency surgery
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
Incidence of Difficult Intubation
Time frame: Perioperative
Difficult intubation defined as Cormack-Lehane grade III or IV and/or the need for additional airway devices or techniques during tracheal intubation.
4 secondary outcomes
Ultrasonographic Measurement of Tongue Thickness
Time frame: Preoperative assessment
Ultrasonographic Measurement of Skin-to-Hyoid Bone Distance
Time frame: Preoperative assessment
Ultrasonographic Measurement of Skin-to-Epiglottis Distance
Time frame: Preoperative assessment
Ultrasonographic Measurement of Distance from Skin to Anterior Commissure of the Vocal Cords
Time frame: Preoperative assessment
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 15 Jan 2026.
- Derived from this study: PubMed 42098606Citilcioglu US, Ozdogan HK, Yalim H, Atasever UB. Preoperative airway ultrasonography for predicting difficult intubation in adult female patients: a prospective observational study. BMC Anesthesiol. 2026 May 7;26(1):386. doi: 10.1186/s12871-026-03891-z.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Intubation and Airway Assessment, run by Adana City Training 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 5 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 15 Jan 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?
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?
Incidence of Difficult Intubation (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343557, which also lists 1 linked publication.
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 15 Jan 2026.