Awake IntubationNCT06279416
Expected Difficult Airway Management
An observational study of Awake Intubation and Advanced Airway Techniques, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Awake Intubation, Advanced Airway Techniques
- What is being tested?
- fiberoptic intubation, laryngeal mask airway-mediated aintree catheter and videolaryngoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were previously evaluated for difficult airway criteria and predicted to have a difficult airway or who could not be ventilated or intubated after induction of anesthesia in another center.
Who may be able to join
- Over 18 years old
- Meets the expected difficult airway criteria
- Being awakened after induction of anesthesia in another center
- At least one of the awake intubation criteria in the DAS 2022 guideline
- Elective surgeries
Who cannot join
- Emergency surgeries
- Patients intubated with anesthesia
- Noncoopere patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Advanced Airway Methods Applied to Patients Who Were Awakened Due to Difficult Airway in Another Center or Who Were Predicted to Have Difficult Airway in Preoperative Evaluation
In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded.
Read the detailed description
Patients who meet the inclusion criteria will be informed about the difficult airway and their verbal and written consent will be obtained.
When participants are taken to the room, an observer will be in the operation room. There was no emergency to the patient's primary anesthesiologist, will not be involved. Record patients' demographic data, Mallampati scores, thyromental distance, and neck circumference.
The airway method preferred by the physician, procedure duration, number of attempts, success, and complications will be recorded.
- Conditions
- Awake Intubation, Advanced Airway Techniques
- Being tested
- fiberoptic intubation, laryngeal mask airway-mediated aintree catheter, videolaryngoscopy
- Keywords
- videolaryngoscopy, fiberoptic bronchoscope, supraglottic airway device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic intubationProcedure or surgery
awake nasal fiberoptic intubation
laryngeal mask airway-mediated aintree catheterProcedure or surgery
awake intubation with laryngeal mask airway-mediated aintree catheter
videolaryngoscopyProcedure or surgery
awake intubation with videolaryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| grup-1: awake nasal fiberoptic intubation | awake nasal fiberoptic intubation Receives: Procedure: fiberoptic intubation | |
| grup-2: awake intubation with laryngeal mask airway-mediated aintree catheter | awake intubation with laryngeal mask airway-mediated aintree catheter Receives: Procedure: laryngeal mask airway-mediated aintree catheter | |
| grup-3: awake intubation with videolaryngoscopy | awake intubation with videolaryngoscopy Receives: Procedure: videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of advanced airway methods in the awake patient with difficult airway.
Comparison of the superiority of advanced airway methods applied to the expected difficult airway patient in the operating room. The number of attempts and duration for successful intubation between groups will be examined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start30 Dec 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 Awake 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehmet Yilmaz, Principal investigator, Kocaeli City Hospital Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279416
- Sponsor's protocol ID
- 2023-31
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz M, Yuksek A, Civraz AZT, Kara MY, Candan S, Saracoglu KT, Saracoglu A. Supraglottic airway devices in awake tracheal intubation: a viable alternative to fiberoptic and video laryngoscopy. BMC Anesthesiol. 2025 Oct 7;25(1):485. doi: 10.1186/s12871-025-03331-4.
PubMed 41057781
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Airway Methods Applied to Patients Who Were Awakened Due to Difficult Airway in Another Center or Who Were Predicted to Have Difficult Airway in Preoperative Evaluation
- ClinicalTrials.gov ID
- NCT06279416
- Acronym / sponsor ID
- 2023-31
- Conditions
- Awake Intubation, Advanced Airway Techniques
- Keywords
- videolaryngoscopy, fiberoptic bronchoscope, supraglottic airway device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 28 Feb 2024 (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.
In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded.
Detailed description
Patients who meet the inclusion criteria will be informed about the difficult airway and their verbal and written consent will be obtained.
When participants are taken to the room, an observer will be in the operation room. There was no emergency to the patient's primary anesthesiologist, will not be involved. Record patients' demographic data, Mallampati scores, thyromental distance, and neck circumference.
The airway method preferred by the physician, procedure duration, number of attempts, success, and complications will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| grup-1: awake nasal fiberoptic intubation | – | Procedure: fiberoptic intubationawake nasal fiberoptic intubation |
| grup-2: awake intubation with laryngeal mask airway-mediated aintree catheter | – | Procedure: laryngeal mask airway-mediated aintree catheterawake intubation with laryngeal mask airway-mediated aintree catheter |
| grup-3: awake intubation with videolaryngoscopy | – | Procedure: videolaryngoscopyawake intubation with videolaryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were previously evaluated for difficult airway criteria and predicted to have a difficult airway or who could not be ventilated or intubated after induction of anesthesia in another center.
Key inclusion criteria (5 listed)
- Over 18 years old
- Meets the expected difficult airway criteria
- Being awakened after induction of anesthesia in another center
- At least one of the awake intubation criteria in the DAS 2022 guideline
- Elective surgeries
Key exclusion criteria (3 listed)
- Emergency surgeries
- Patients intubated with anesthesia
- Noncoopere patients
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 |
|---|---|---|
| fiberoptic intubationawake nasal fiberoptic intubation | Procedure or surgery | grup-1: awake nasal fiberoptic intubation |
| laryngeal mask airway-mediated aintree catheterawake intubation with laryngeal mask airway-mediated aintree catheter | Procedure or surgery | grup-2: awake intubation with laryngeal mask airway-mediated aintree catheter |
| videolaryngoscopyawake intubation with videolaryngoscopy | Procedure or surgery | grup-3: awake intubation with videolaryngoscopy |
Primary outcome
Comparison of advanced airway methods in the awake patient with difficult airway.
Time frame: 1 year
Comparison of the superiority of advanced airway methods applied to the expected difficult airway patient in the operating room. The number of attempts and duration for successful intubation between groups will be examined.
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 2025.
- Derived from this study: PubMed 41057781Yilmaz M, Yuksek A, Civraz AZT, Kara MY, Candan S, Saracoglu KT, Saracoglu A. Supraglottic airway devices in awake tracheal intubation: a viable alternative to fiberoptic and video laryngoscopy. BMC Anesthesiol. 2025 Oct 7;25(1):485. doi: 10.1186/s12871-025-03331-4.
Related trials for Awake Intubation
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Recruiting
High-flow Nasal Cannula Versus Conventional Oxygen During Awake Tracheal Intubation With Difficult Airways
Awake Tracheal Intubation, Difficult Airway
Not yet recruiting
COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION
Blood Pressure After Nerve Block, Hemodynamic Stability During Awake Intubation
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.
Mehmet Yilmaz principal investigator
Kocaeli City Hospital Anesthesiology and Reanimation
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 Awake Intubation and Advanced Airway Techniques, run by Kocaeli 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 5 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 15 Jan 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?
Comparison of advanced airway methods in the awake patient with difficult airway. (time frame: 1 year). 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 NCT06279416, 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 2025; AzTrials last refreshed its copy on 28 Oct 2026.