Airway ManagementNCT07057908
Comparison of Intubation Using Video Laryngeal Mask and Video Laryngoscope in Elective Surgical Patients
An observational study of Airway Management and Tracheal Intubation, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Tracheal Intubation, Elective Surgeries
- What is being tested?
- Video Laryngoscope Intubation with Bougie and Video Laryngeal Mask Airway (SaCoVLM) Intubation with Bougie
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 2 Mar 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients aged 18 years and older, classified as ASA I to III, who are scheduled to undergo elective surgical procedures under general anesthesia. All participants will require tracheal intubation using either a video laryngoscope or a video laryngeal mask airway (SaCoVLM), both with bougie assistance.
Who may be able to join
- Adult patients aged 18 years and older
- Patients scheduled for elective surgical procedures
- Patients classified as ASA Physical Status I-III
- Patients undergoing general anesthesia
Who cannot join
- Patients younger than 18 years
- Patients undergoing emergency surgery
- Patients with difficult airway predictors, such as:
- Mallampati score ≥ 3
- Thyromental distance < 6 cm
- Mouth opening < 3 cm
Show all 9Show fewer
- Patients with anatomical abnormalities or surgical history involving the oropharynx, larynx, or airway
- Patients with conditions contraindicating head or neck manipulation (e.g., cervical instability, upper airway tumors)
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadim, 55000
About this study
Official title: A Prospective Observational Study Comparing Tracheal Intubation Via Video Laryngeal Mask Airway and Video Laryngoscope in Adult Patients Undergoing Elective Surgery
This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Our main focus is to measure how long intubation takes with each device and to see how successful the intubation is. The study does not involve any extra procedures or risks; everything will be carried out as part of normal patient care.
Read the detailed description
In this prospective observational study, we will compare two airway devices commonly used during elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will involve adult patients (18 years and older, ASA physical status I-III) scheduled to undergo surgery under general anesthesia at Samsun University Training and Research Hospital.
Patients will be assigned to one of two groups. In one group, intubation will be performed using a video laryngoscope; in the other group, a video laryngeal mask will be used. In both groups, tracheal intubation will be carried out with the assistance of a bougie after device placement.
The primary outcome of the study will be intubation time, defined as the duration from insertion of the device until successful confirmation of tracheal intubation. Secondary outcomes will include ease of insertion, the need for additional maneuvers, and complications such as desaturation, trauma, or failed attempts.
Since both techniques, as well as bougie use, are already part of routine anesthesia practice, no extra interventions or risks will be introduced. The aim of the study is to compare the performance of these two devices under everyday clinical conditions.
- Conditions
- Airway Management, Tracheal Intubation, Elective Surgeries, Videolaryngoscopy, Anaesthesia
- Being tested
- Video Laryngoscope Intubation with Bougie, Video Laryngeal Mask Airway (SaCoVLM) Intubation with Bougie
- Keywords
- Video Laryngoscope, Video Laryngeal Mask Airway, SaCoVLM, Intubation Success Rate, Observational Study, Elective Surgical Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Laryngoscope Intubation with BougieProcedure or surgery
Participants in this group will undergo tracheal intubation using a video laryngoscope under general anesthesia. After induction, a standard bougie will be advanced through the vocal cords under video guidance, and the endotracheal tube will be railroaded over the bougie into the trachea.
The primary outcome will be intubation time, measured from insertion of the device until confirmation of successful tracheal intubation. Additional parameters such as intubation success rate, ease of insertion, and complications (e.g., desaturation, airway trauma, failed attempts) will also be recorded. No extra procedures will be performed beyond routine airway management.
Video Laryngeal Mask Airway (SaCoVLM) Intubation with BougieProcedure or surgery
Participants in this group will undergo tracheal intubation using a video laryngeal mask airway (SaCoVLM) under general anesthesia. After successful placement of the device, a standard bougie will be inserted through the SaCoVLM's dedicated lumen, and an endotracheal tube will be advanced over the bougie into the trachea under video guidance.
The primary outcome will be intubation time, defined as the duration from device insertion to confirmation of successful intubation. Secondary outcomes include intubation success rate, ease of insertion, and complications such as desaturation, trauma, or failed attempts. As both techniques are part of routine practice, no additional risks will be introduced.
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngoscope | Tracheal intubation using a video laryngoscope assisted with a bougie in adult patients undergoing elective surgery. Receives: Procedure: Video Laryngeal Mask Airway (SaCoVLM) Intubation with Bougie | |
| Video Laryngeal Mask Airway (SaCoVLM) | Tracheal intubation performed through a video laryngeal mask airway (SaCoVLM) with bougie assistance in adult patients undergoing elective surgery. Receives: Procedure: Video Laryngoscope Intubation with Bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful Intubation
The time from when the endotracheal tube passes the upper incisors to the appearance of three consecutive end-tidal CO₂ (ETCO₂) waveforms on the capnograph. This will be used as the objective marker of successful tracheal intubation. Timing will be recorded in seconds by an independent observer using a stopwatch.
Measured: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)
Secondary outcomes (2)
First-Attempt Intubation Success Rate
Defined as successful tracheal intubation on the first attempt, confirmed by visualization of three consecutive ETCO₂ waveforms and bilateral chest expansion.
The outcome will be recorded as a binary variable:
Yes = Successful on first attempt
No = Failed or required multiple attempts
Measured: Immediately after intubation
Insertion-Related Complications
Complications related to the airway device or bougie use, including desaturation (SpO₂ < 92%), oropharyngeal trauma (visible bleeding), or need for additional maneuvers.
Measured: Intraoperative and early postoperative period (0-30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice S Kuşderci, Study director, Samsun University Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057908
- Sponsor's protocol ID
- GOKAEK 2025/10/1
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sargin M, Uluer MS. Comparison of McGrath((R)) Series 5 video laryngoscope with Macintosh laryngoscope: A prospective, randomised trial in patients with normal airways. Pak J Med Sci. 2016 Jul-Aug;32(4):869-74. doi: 10.12669/pjms.324.10037.
PubMed 27648030Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
PubMed 9754506Sun Y, Huang L, Xu L, Zhang M, Guo Y, Wang Y. The Application of a SaCoVLMTM Visual Intubation Laryngeal Mask for the Management of Difficult Airways in Morbidly Obese Patients: Case Report. Front Med (Lausanne). 2021 Nov 18;8:763103. doi: 10.3389/fmed.2021.763103. eCollection 2021.
PubMed 34869469
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Comparing Tracheal Intubation Via Video Laryngeal Mask Airway and Video Laryngoscope in Adult Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT07057908
- Acronym / sponsor ID
- GOKAEK 2025/10/1
- Conditions
- Airway Management, Tracheal Intubation, Elective Surgeries, Videolaryngoscopy, Anaesthesia
- Keywords
- Video Laryngoscope, Video Laryngeal Mask Airway, SaCoVLM, Intubation Success Rate, Observational Study, Elective Surgical Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 10 Jul 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.
This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Our main focus is to measure how long intubation takes with each device and to see how successful the intubation is. The study does not involve any extra procedures or risks; everything will be carried out as part of normal patient care.
Detailed description
In this prospective observational study, we will compare two airway devices commonly used during elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will involve adult patients (18 years and older, ASA physical status I-III) scheduled to undergo surgery under general anesthesia at Samsun University Training and Research Hospital.
Patients will be assigned to one of two groups. In one group, intubation will be performed using a video laryngoscope; in the other group, a video laryngeal mask will be used. In both groups, tracheal intubation will be carried out with the assistance of a bougie after device placement.
The primary outcome of the study will be intubation time, defined as the duration from insertion of the device until successful confirmation of tracheal intubation. Secondary outcomes will include ease of insertion, the need for additional maneuvers, and complications such as desaturation, trauma, or failed attempts.
Since both techniques, as well as bougie use, are already part of routine anesthesia practice, no extra interventions or risks will be introduced. The aim of the study is to compare the performance of these two devices under everyday clinical conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscope | – | Procedure: Video Laryngeal Mask Airway (SaCoVLM) Intubation with BougieTracheal intubation using a video laryngoscope assisted with a bougie in adult patients undergoing elective surgery. |
| Video Laryngeal Mask Airway (SaCoVLM) | – | Procedure: Video Laryngoscope Intubation with BougieTracheal intubation performed through a video laryngeal mask airway (SaCoVLM) with bougie assistance in adult patients undergoing elective surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older, classified as ASA I to III, who are scheduled to undergo elective surgical procedures under general anesthesia. All participants will require tracheal intubation using either a video laryngoscope or a video laryngeal mask airway (SaCoVLM), both with bougie assistance.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years and older
- Patients scheduled for elective surgical procedures
- Patients classified as ASA Physical Status I-III
- Patients undergoing general anesthesia
Key exclusion criteria (9 listed)
- Patients younger than 18 years
- Patients undergoing emergency surgery
- Patients with difficult airway predictors, such as:
- Mallampati score ≥ 3
- Thyromental distance < 6 cm
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 |
|---|---|---|
| Video Laryngoscope Intubation with BougieParticipants in this group will undergo tracheal intubation using a video laryngoscope under general anesthesia. After induction, a standard bougie will be advanced through the vocal cords under video guidance, and the endotracheal tube will be railroaded over the bougie into the trachea. The primary outcome will be intubation time, measured from insertion of the device until confirmation of successful tracheal intubation. Additional parameters such as intubation success rate, ease of insertion, and complications (e.g., desaturation, airway trauma, failed attempts) will also be recorded. No extra procedures will be performed beyond routine airway management. | Procedure or surgery | Video Laryngeal Mask Airway (SaCoVLM) |
| Video Laryngeal Mask Airway (SaCoVLM) Intubation with BougieParticipants in this group will undergo tracheal intubation using a video laryngeal mask airway (SaCoVLM) under general anesthesia. After successful placement of the device, a standard bougie will be inserted through the SaCoVLM's dedicated lumen, and an endotracheal tube will be advanced over the bougie into the trachea under video guidance. The primary outcome will be intubation time, defined as the duration from device insertion to confirmation of successful intubation. Secondary outcomes include intubation success rate, ease of insertion, and complications such as desaturation, trauma, or failed attempts. As both techniques are part of routine practice, no additional risks will be introduced. | Procedure or surgery | Video Laryngoscope |
Primary outcome
Time to Successful Intubation
Time frame: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)
The time from when the endotracheal tube passes the upper incisors to the appearance of three consecutive end-tidal CO₂ (ETCO₂) waveforms on the capnograph. This will be used as the objective marker of successful tracheal intubation. Timing will be recorded in seconds by an independent observer using a stopwatch.
2 secondary outcomes
First-Attempt Intubation Success Rate
Time frame: Immediately after intubation
Insertion-Related Complications
Time frame: Intraoperative and early postoperative period (0-30 minutes)
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 5 Sep 2025.
- Background: PubMed 27648030Sargin M, Uluer MS. Comparison of McGrath((R)) Series 5 video laryngoscope with Macintosh laryngoscope: A prospective, randomised trial in patients with normal airways. Pak J Med Sci. 2016 Jul-Aug;32(4):869-74. doi: 10.12669/pjms.324.10037.
- Background: PubMed 9754506Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
- Background: PubMed 34869469Sun Y, Huang L, Xu L, Zhang M, Guo Y, Wang Y. The Application of a SaCoVLMTM Visual Intubation Laryngeal Mask for the Management of Difficult Airways in Morbidly Obese Patients: Case Report. Front Med (Lausanne). 2021 Nov 18;8:763103. doi: 10.3389/fmed.2021.763103. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Hatice S Kuşderci study director
Samsun University Faculty of Medicine, Department of 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 Airway Management and Tracheal Intubation, run by Samsun 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 4 inclusion and 9 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 5 Sep 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?
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 Mehmet Göhan Taflan (+90 535 211 40 70, drmehmettaflan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful Intubation (time frame: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)). 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 NCT07057908, which also lists 3 linked publications.
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 5 Sep 2025.