Tympanoplasty SurgeryNCT07084636
Comparative of Video Laryngeal Mask and Endotracheal Intubation in Patients Undergoing Tympanoplasty Surgery.
A study testing Video Laryngeal Mask and Endotracheal intubation in people with Tympanoplasty Surgery and Laryngeal Mask Airway, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tympanoplasty Surgery, Laryngeal Mask Airway
- What is being tested?
- Video Laryngeal Mask and Endotracheal intubation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 17 Jul 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18-75
- Participants with ASA I-II-III
- Cases with surgery duration of less than two hours
Who cannot join
- Participants under 18 years of age
- Participants who are pregnant
- Participants with a difficult airway diagnosis
- Participants with a mouth opening of less than 4 cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadım, 55000
About this study
Official title: Comparative Study of Video Laryngeal Mask and Endotracheal Intubation in Airway Management in Patients Undergoing Tympanoplasty Surgery.
The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated.
Read the detailed description
Procedures to be performed under general anesthesia are performed by placing endotracheal intubation and laryngeal mask in the airway. Video Laryngeal Mask (LMA) combines the upper glottic airway device with video laryngoscope tracheal intubation. LMA placement and tracheal intubation can be visualized, LMA position can be continuously monitored during the operation, and adverse events such as LMA displacement can be managed in a timely manner. Studies have shown that video LMA has extraordinary advantages in airway management. This study aimed to compare video LMA and endotracheal intubation in participants who will undergo tympanoplasty surgery.
- Conditions
- Tympanoplasty Surgery, Laryngeal Mask Airway
- Being tested
- Video Laryngeal Mask, Endotracheal intubation
- Keywords
- tympanoplasty, video laryngeal mask, airway, intubation, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Laryngeal MaskOther
Video laryngeal mask will be used in this group
Endotracheal intubationOther
Endotracheal intubation will be performed in this group.
| Study group | Role | What they receive |
|---|---|---|
| Group Laryngeal Mask Airway | Active comparator | In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously. A laryngeal mask will be placed after induction, the cuf will be inflated and fixed with a cuf manometer. Receives: Other: Video Laryngeal Mask |
| Group Endotracheal Tube | Active comparator | In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously, 1 mcg/kg fentanyl will be administered intravenously. Additionally, 0.6 mg/kg rocuronium will be administered intravenously and endotracheal intubation will be performed, and the cuff will be inflated and fixed with a cuff manometer. Receives: Other: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Effective Airway
The time to achieve an effective airway was defined as the time between removing the face mask, attaching the airway device, and obtaining 3 square wave capnograph traces with manual ventilation.
Measured: Baseline
Secondary outcomes (4)
Number of attempts taken for successful placement of airway device
Number of attempts needed for successful placement of either the SaCoVLM™ video laryngeal mask airway the tracheal tube, as assigned
Measured: Baseline
Haemodynamic response to insertion of airway device
Systolic blood pressure and heart rate at 0th minute, 1st minute 5th minute, starting from the time the face mask was removed from the patient's face.
Measured: Baseline, 1st minute, 5th minute
Displacement of the SaCoVLM™ video laryngeal mask in head position
Effect of Head Rotation During Tympanoplasty on laryngeal visibility with the SaCoVLM™ Laryngeal Mask during head rotation
Measured: Baseline
Incidence of post-operative sore throat
postoperative sore throat will be recorded at 1st hour, 6th hour, 12th hour, 18th hour, 24th hour
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Dec 2024
- Primary completion5 Jul 2025
- Study completion17 Jul 2025
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 Tympanoplasty SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HATİCE SELÇUK KUŞDERCİ, asst prof, Study director, SAMSUN UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084636
- Sponsor's protocol ID
- GOKAEK 2024/21/10
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Sun 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 34869469Yan CL, Chen Y, Sun P, Qv ZY, Zuo MZ. Preliminary evaluation of SaCoVLM video laryngeal mask airway in airway management for general anesthesia. BMC Anesthesiol. 2022 Jan 3;22(1):3. doi: 10.1186/s12871-021-01541-0.
PubMed 34979936Choi WJ, Kim YH. The influence of head rotation on ProSeal laryngeal mask airway sealing during paediatric myringotomy. Anaesth Intensive Care. 2007 Dec;35(6):957-60. doi: 10.1177/0310057X0703500617.
PubMed 18084990
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Video Laryngeal Mask and Endotracheal Intubation in Airway Management in Patients Undergoing Tympanoplasty Surgery.
- ClinicalTrials.gov ID
- NCT07084636
- Acronym / sponsor ID
- GOKAEK 2024/21/10
- Conditions
- Tympanoplasty Surgery, Laryngeal Mask Airway
- Keywords
- tympanoplasty, video laryngeal mask, airway, intubation, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 24 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.
The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated.
Detailed description
Procedures to be performed under general anesthesia are performed by placing endotracheal intubation and laryngeal mask in the airway. Video Laryngeal Mask (LMA) combines the upper glottic airway device with video laryngoscope tracheal intubation. LMA placement and tracheal intubation can be visualized, LMA position can be continuously monitored during the operation, and adverse events such as LMA displacement can be managed in a timely manner. Studies have shown that video LMA has extraordinary advantages in airway management. This study aimed to compare video LMA and endotracheal intubation in participants who will undergo tympanoplasty surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Laryngeal Mask Airway | Active comparator | Other: Video Laryngeal MaskIn this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously. A laryngeal mask will be placed after induction, the cuf will be inflated and fixed with a cuf manometer. |
| Group Endotracheal Tube | Active comparator | Other: Endotracheal intubationIn this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously, 1 mcg/kg fentanyl will be administered intravenously. Additionally, 0.6 mg/kg rocuronium will be administered intravenously and endotracheal intubation will be performed, and the cuff will be inflated and fixed with a cuff manometer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 18-75
- Participants with ASA I-II-III
- Cases with surgery duration of less than two hours
Key exclusion criteria (4 listed)
- Participants under 18 years of age
- Participants who are pregnant
- Participants with a difficult airway diagnosis
- Participants with a mouth opening of less than 4 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 Laryngeal MaskVideo laryngeal mask will be used in this group | Other | Group Laryngeal Mask Airway |
| Endotracheal intubationEndotracheal intubation will be performed in this group. | Other | Group Endotracheal Tube |
Primary outcome
Time to Effective Airway
Time frame: Baseline
The time to achieve an effective airway was defined as the time between removing the face mask, attaching the airway device, and obtaining 3 square wave capnograph traces with manual ventilation.
4 secondary outcomes
Number of attempts taken for successful placement of airway device
Time frame: Baseline
Haemodynamic response to insertion of airway device
Time frame: Baseline, 1st minute, 5th minute
Displacement of the SaCoVLM™ video laryngeal mask in head position
Time frame: Baseline
Incidence of post-operative sore throat
Time frame: 24 hours after surgery
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 24 Jul 2025.
- 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.
- Background: PubMed 34979936Yan CL, Chen Y, Sun P, Qv ZY, Zuo MZ. Preliminary evaluation of SaCoVLM video laryngeal mask airway in airway management for general anesthesia. BMC Anesthesiol. 2022 Jan 3;22(1):3. doi: 10.1186/s12871-021-01541-0.
- Background: PubMed 18084990Choi WJ, Kim YH. The influence of head rotation on ProSeal laryngeal mask airway sealing during paediatric myringotomy. Anaesth Intensive Care. 2007 Dec;35(6):957-60. doi: 10.1177/0310057X0703500617.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
HATİCE SELÇUK KUŞDERCİ, asst prof study director
SAMSUN UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngeal Mask and Endotracheal intubation in people with Tympanoplasty Surgery and Laryngeal Mask Airway, 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 3 inclusion and 4 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 24 Jul 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?
Time to Effective Airway (time frame: Baseline). 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 NCT07084636, 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 24 Jul 2025.