Difficult AirwayNCT06972394
Videolaryngoscopy at Unanticipated Difficult Airway
An observational study of Difficult Airway and Videolaryngoscopy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Glottic visualization, intubation success, complications and accidental esophageal intubation rate of direct laryngoscopy (DL) and videolaryngoscopy (VL) were compared in patients with UDA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Difficult Airway, Videolaryngoscopy
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Apr 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of patients with no signs of difficult airway (unanticipated difficult airway) in preoperative evaluation will be investigated retrospectively.
Who may be able to join
- Patients aged 18 to 90 years
- Patients with unanticipated difficult airway
Who cannot join
- Patients with missing data
- Patients with a history of difficult airway
- Patients with signs of difficult airway on preoperative evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Center, 60100
About this study
Official title: Should Videolaryngoscopy Enter Routine Use? Unanticipated Difficult Airway: A Five-Year Experience in a Tertiary Care Hospital
Glottic visualization, intubation success, complications and accidental esophageal intubation rate of direct laryngoscopy (DL) and videolaryngoscopy (VL) were compared in patients with UDA.
Read the detailed description
Ethical approval for this study was obtained from the Clinical Research Ethics Committee of Tokat Gaziosmanpaşa University (25-MOBAEK-124). Data were collected by reviewing hospital automation systems, patient records, and difficult airway forms for patients who underwent elective surgery under general anesthesia and experienced unanticipated difficult airway (UDA) between January 2020 and March 2025. Patients with incomplete data, a prior history of difficult airway, or preoperative findings indicating a difficult airway were excluded from the study. Demographic variables-including age, gender, body mass index, comorbidities, and ASA scores-as well as airway examination findings such as Mallampati scores and Cormack-Lehane grades, were analyzed. Additionally, intubation methods, instruments used, and challenges encountered during airway management were evaluated. The effects of direct laryngoscopy (DL) and videolaryngoscopy (VL) on glottic visualization, intubation success, and complication rates were also compared.
In the relevant clinic, preoperative airway evaluation is performed by assessing the Mallampati classification, thyromental distance, sternomental distance, inter-incisor gap and angle, neck circumference, atlanto-occipital joint mobility, upper lip bite test, retrognathia, prominent upper incisors, high and narrow palate, macroglossia, hoarseness, dyspnea on exertion, and history of difficult airway. In patients without any predictors of difficult airway, routine intubation is performed using DL in the sniffing position. The management of patients with UDA is conducted according to a specific institutional protocol. In appropriate cases where mask ventilation and oxygenation can be maintained, a hyper-angulated C-MAC® D-Blade videolaryngoscope (Karl Storz, Tuttlingen, Germany) is used as a rescue technique in patients who cannot be intubated using DL. If tracheal intubation cannot be achieved with videolaryngoscopy or other methods and the patient is awakened, and if the surgical procedure still requires general anesthesia, awake intubation using fiberoptic bronchoscopy (FOB) is planned.
- Conditions
- Difficult Airway, Videolaryngoscopy
- Keywords
- Anesthesia, intubation, airway management, laryngoscopy, difficult airway, videolaryngoscopy
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 |
|---|---|---|
| Patients with unanticipated difficult airway | In the present study, the records of patients with unanticipated difficult airway in the clinic were retrospectively reviewed. The aim was to compare the effects of direct laryngoscopy and videolaryngoscopy on glottic visualization, intubation success, and complications in patients with unanticipated difficult airway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success
Successful intubation rate with DL or VL in patients with unpredictable difficult airway
Measured: From anesthesia induction until the attempt of intubation is completed (peri-induction period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jan 2020
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
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
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972394
- Sponsor's protocol ID
- 25-MOBAEK-124
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Preoperative airway findings of patients, devices used in airway management and their results and complications
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Videolaryngoscopy Enter Routine Use? Unanticipated Difficult Airway: A Five-Year Experience in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06972394
- Acronym / sponsor ID
- 25-MOBAEK-124
- Conditions
- Difficult Airway, Videolaryngoscopy
- Keywords
- Anesthesia, intubation, airway management, laryngoscopy, difficult airway, videolaryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 15 May 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.
Glottic visualization, intubation success, complications and accidental esophageal intubation rate of direct laryngoscopy (DL) and videolaryngoscopy (VL) were compared in patients with UDA.
Detailed description
Ethical approval for this study was obtained from the Clinical Research Ethics Committee of Tokat Gaziosmanpaşa University (25-MOBAEK-124). Data were collected by reviewing hospital automation systems, patient records, and difficult airway forms for patients who underwent elective surgery under general anesthesia and experienced unanticipated difficult airway (UDA) between January 2020 and March 2025. Patients with incomplete data, a prior history of difficult airway, or preoperative findings indicating a difficult airway were excluded from the study. Demographic variables-including age, gender, body mass index, comorbidities, and ASA scores-as well as airway examination findings such as Mallampati scores and Cormack-Lehane grades, were analyzed. Additionally, intubation methods, instruments used, and challenges encountered during airway management were evaluated. The effects of direct laryngoscopy (DL) and videolaryngoscopy (VL) on glottic visualization, intubation success, and complication rates were also compared.
In the relevant clinic, preoperative airway evaluation is performed by assessing the Mallampati classification, thyromental distance, sternomental distance, inter-incisor gap and angle, neck circumference, atlanto-occipital joint mobility, upper lip bite test, retrognathia, prominent upper incisors, high and narrow palate, macroglossia, hoarseness, dyspnea on exertion, and history of difficult airway. In patients without any predictors of difficult airway, routine intubation is performed using DL in the sniffing position. The management of patients with UDA is conducted according to a specific institutional protocol. In appropriate cases where mask ventilation and oxygenation can be maintained, a hyper-angulated C-MAC® D-Blade videolaryngoscope (Karl Storz, Tuttlingen, Germany) is used as a rescue technique in patients who cannot be intubated using DL. If tracheal intubation cannot be achieved with videolaryngoscopy or other methods and the patient is awakened, and if the surgical procedure still requires general anesthesia, awake intubation using fiberoptic bronchoscopy (FOB) is planned.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unanticipated difficult airway | – | –In the present study, the records of patients with unanticipated difficult airway in the clinic were retrospectively reviewed. The aim was to compare the effects of direct laryngoscopy and videolaryngoscopy on glottic visualization, intubation success, and complications in patients with unanticipated difficult airway. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of patients with no signs of difficult airway (unanticipated difficult airway) in preoperative evaluation will be investigated retrospectively.
Key inclusion criteria (2 listed)
- Patients aged 18 to 90 years
- Patients with unanticipated difficult airway
Key exclusion criteria (3 listed)
- Patients with missing data
- Patients with a history of difficult airway
- Patients with signs of difficult airway on preoperative evaluation
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
Intubation success
Time frame: From anesthesia induction until the attempt of intubation is completed (peri-induction period).
Successful intubation rate with DL or VL in patients with unpredictable difficult airway
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 16 May 2025.
- Individual participant dataSharing planned: Yes. Preoperative airway findings of patients, devices used in airway management and their results and complications
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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 Airway and Videolaryngoscopy, run by Tokat Gaziosmanpasa University 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 2 inclusion and 3 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 16 May 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?
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?
Intubation success (time frame: From anesthesia induction until the attempt of intubation is completed (peri-induction period).). 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 16 May 2025.