Difficult Tracheal Intubationpreop-airwayNCT07881107
Preoperative Airway Assessment and Difficult Tracheal Intubation
An observational study of Difficult Tracheal Intubation and Difficult Laryngoscopy, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study examined the association between preoperative airway assessment findings and difficulty placing a breathing tube during general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Tracheal Intubation, Difficult Laryngoscopy, Difficult Mask Ventilation
- How many people
- 812 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 31 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing general anesthesia with endotracheal intubation at Bursa City Hospital between May 2024 and March 2026. From a source population of 29,814 intubated adults, the analyzed cohort included 759 patients with anticipated difficult airway and 53 with unanticipated difficult airway, totaling 812 patients.
Who may be able to join
- Age 18 years or older.
- General anesthesia with endotracheal intubation at Bursa City Hospital between May 2024 and March 2026.
- Documented anticipated difficult airway before surgery or unanticipated difficult airway during intraoperative airway management.
Who cannot join
- Patients managed exclusively with regional anesthesia without tracheal intubation.
- Patients managed with a laryngeal mask airway instead of endotracheal intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Airway Assessment Findings Associated With Difficult Tracheal Intubation and Characteristics of Unanticipated Difficult Airway: A Retrospective Cohort Study
This retrospective observational study examined the association between preoperative airway assessment findings and difficulty placing a breathing tube during general anesthesia. Existing records of 812 adults at Bursa City Hospital were analyzed, including 759 patients with anticipated and 53 with unanticipated airway difficulty. The primary outcome was the need for more than one intubation attempt. No additional procedures were performed for research purposes.
Read the detailed description
Anesthesia records from operations performed between May 2024 and March 2026 were reviewed retrospectively. Seven routinely documented bedside airway assessment findings were evaluated. Associations with difficult intubation, difficult laryngoscopy, Cormack-Lehane grade III-IV, and difficult mask ventilation were analyzed in the anticipated-difficult-airway group, with adjustment for age and sex. Patients with unanticipated airway difficulty were described separately.
- Keywords
- Preoperative Airway Assessment, Mallampati Classification, Unanticipated Difficult Airway, Cormack-Lehane Grade
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 |
|---|---|---|
| Anticipated Difficult Airway | Adults with clinician-documented anticipated difficult airway at preoperative assessment who underwent general anesthesia with endotracheal intubation (n=759). | |
| Unanticipated Difficult Airway | Adults without documented preoperative suspicion of difficult airway who experienced clinician-documented airway difficulty during general anesthesia with endotracheal intubation (n=53). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult Tracheal Intubation
Proportion of patients requiring more than one tracheal intubation attempt, as documented in anesthesia records.
Measured: During airway management for the index surgery (day 0).
Secondary outcomes (3)
Difficult Laryngoscopy
Proportion of patients with clinician-documented difficulty during direct or video laryngoscopy.
Measured: During laryngoscopy for the index surgery (day 0).
Cormack-Lehane Grade III or IV
Proportion of patients with a documented Cormack-Lehane grade III or IV laryngoscopic view.
Measured: During laryngoscopy for the index surgery (day 0).
Difficult Mask Ventilation
Proportion of patients with clinician-documented difficulty providing adequate face-mask ventilation.
Measured: During anesthesia induction for the index surgery (day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Feb 2026
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Tracheal 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
- Retrospective
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, Serra Topal, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881107
- Sponsor's protocol ID
- bsh0002
- Acronym
- preop-airway
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results, including demographics, preoperative airway assessments, and airway management outcomes, will be available from the corresponding author upon reasonable request, subject to institutional approval and applicable data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Airway Assessment Findings Associated With Difficult Tracheal Intubation and Characteristics of Unanticipated Difficult Airway: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07881107
- Acronym / sponsor ID
- preop-airway / bsh0002
- Keywords
- Preoperative Airway Assessment, Mallampati Classification, Unanticipated Difficult Airway, Cormack-Lehane Grade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ulusoy, Emre, M.D.
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 19 Oct 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 retrospective observational study examined the association between preoperative airway assessment findings and difficulty placing a breathing tube during general anesthesia. Existing records of 812 adults at Bursa City Hospital were analyzed, including 759 patients with anticipated and 53 with unanticipated airway difficulty. The primary outcome was the need for more than one intubation attempt. No additional procedures were performed for research purposes.
Detailed description
Anesthesia records from operations performed between May 2024 and March 2026 were reviewed retrospectively. Seven routinely documented bedside airway assessment findings were evaluated. Associations with difficult intubation, difficult laryngoscopy, Cormack-Lehane grade III-IV, and difficult mask ventilation were analyzed in the anticipated-difficult-airway group, with adjustment for age and sex. Patients with unanticipated airway difficulty were described separately.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticipated Difficult Airway | – | –Adults with clinician-documented anticipated difficult airway at preoperative assessment who underwent general anesthesia with endotracheal intubation (n=759). |
| Unanticipated Difficult Airway | – | –Adults without documented preoperative suspicion of difficult airway who experienced clinician-documented airway difficulty during general anesthesia with endotracheal intubation (n=53). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing general anesthesia with endotracheal intubation at Bursa City Hospital between May 2024 and March 2026. From a source population of 29,814 intubated adults, the analyzed cohort included 759 patients with anticipated difficult airway and 53 with unanticipated difficult airway, totaling 812 patients.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- General anesthesia with endotracheal intubation at Bursa City Hospital between May 2024 and March 2026.
- Documented anticipated difficult airway before surgery or unanticipated difficult airway during intraoperative airway management.
Key exclusion criteria (2 listed)
- Patients managed exclusively with regional anesthesia without tracheal intubation.
- Patients managed with a laryngeal mask airway instead of 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.
Primary outcome
Difficult Tracheal Intubation
Time frame: During airway management for the index surgery (day 0).
Proportion of patients requiring more than one tracheal intubation attempt, as documented in anesthesia records.
3 secondary outcomes
Difficult Laryngoscopy
Time frame: During laryngoscopy for the index surgery (day 0).
Cormack-Lehane Grade III or IV
Time frame: During laryngoscopy for the index surgery (day 0).
Difficult Mask Ventilation
Time frame: During anesthesia induction for the index surgery (day 0).
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results, including demographics, preoperative airway assessments, and airway management outcomes, will be available from the corresponding author upon reasonable request, subject to institutional approval and applicable data protection requirements.
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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 Tracheal Intubation and Difficult Laryngoscopy, run by Bursa 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 2 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 19 Oct 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?
Difficult Tracheal Intubation (time frame: During airway management for the index surgery (day 0).). 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 19 Oct 2026.