Airway ManagementNCT07912619
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
A study testing Second-Generation SafeLM LMA and Third-Generation SafeLM Video LMA in people with Airway Management and Anesthesia, General, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares two airway devices used during general anesthesia in children: a second-generation laryngeal mask (SafeLM LMA) and a third-generation video laryngeal mask (SafeLM Video LMA). Both devices are CE-marked and routinely used in clinical practice. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- What is being tested?
- Second-Generation SafeLM LMA and Third-Generation SafeLM Video LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Feb 2027
- Phase
- Interventional
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-8 years
- ASA physical status I-II
- Scheduled for elective surgery
- Expected surgical duration <90 minutes
- Written informed consent obtained from parent/guardian
Who cannot join
- Obesity (BMI >95th percentile)
- Oropharyngeal or laryngeal pathology
- Coagulopathy or bleeding diathesis
- Parental/guardian refusal of consent
- Surgery requiring lateral or prone position
- ASA physical status III or higher
Show all 12Show fewer
- Anticipated difficult airway (e.g., dysmorphic facial features)
- Upper respiratory tract infection within the past 2 weeks
- Chronic asthma, bronchitis, or other airway disease
- Gastroesophageal reflux disease (GERD)
- Emergency surgery
- Inadequate fasting time or increased aspiration risk
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
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa
About this study
Official title: Effects of Second-Generation Laryngeal Mask Airway Versus Third-Generation Video Laryngeal Mask Airway on Airway Management in Pediatric Patients
This study compares two airway devices used during general anesthesia in children: a second-generation laryngeal mask (SafeLM LMA) and a third-generation video laryngeal mask (SafeLM Video LMA). Both devices are CE-marked and routinely used in clinical practice. The study will include 90 children aged 2 to 8 years who are scheduled for elective surgery. Children will be randomly assigned to one of two groups (45 per group), and one of the two devices will be placed after anesthesia induction. The main outcome is oropharyngeal leak pressure, which shows how well the mask seals the airway. Other outcomes include success at the first insertion attempt, number of attempts, view of the vocal cords (video group), heart rate and blood pressure changes, and complications such as laryngospasm, low oxygen levels, sore throat, hoarseness, and nausea/vomiting. The study aims to show whether video-guided placement improves airway seal and safety in children.
- Conditions
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- Being tested
- Second-Generation SafeLM LMA, Third-Generation SafeLM Video LMA
- Keywords
- Laryngeal Mask, Video Laryngeal Mask, Supraglottic Airway, Oropharyngeal Leak Pressure, Pediatric, SafeLM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-Generation SafeLM LMADevice
A second-generation supraglottic airway device (SafeLM LMA) inserted after standard anesthesia induction to secure the airway. This device does not include a camera or video guidance component.
Third-Generation SafeLM Video LMADevice
A third-generation video-guided supraglottic airway device (SafeLM Video LMA) inserted after standard anesthesia induction. The integrated adjustable camera provides real-time visualization to guide correct placement.
| Study group | Role | What they receive |
|---|---|---|
| Second-Generation SafeLM LMA | Active comparator | Participants received a second-generation SafeLM laryngeal mask airway (LMA) after standard anesthesia induction, placed without using the video/camera component. Receives: Device: Second-Generation SafeLM LMA |
| Third-Generation SafeLM Video LMA | Experimental | Participants received a third-generation SafeLM video laryngeal mask airway (LMA) after standard anesthesia induction, with the integrated camera system actively used to guide placement. Receives: Device: Third-Generation SafeLM Video LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Leak Pressure (OLP)
Oropharyngeal leak pressure measured immediately after airway device placement, reflecting the sealing performance of the supraglottic airway.
Measured: Measured immediately after device placement
Secondary outcomes (9)
First-Attempt Success Rate
Proportion of participants in whom the airway device was successfully placed on the first insertion attempt.
Measured: During device insertion (intraoperative)
Number of Insertion Attempts
Total number of attempts required to successfully place the airway device.
Measured: During device insertion (intraoperative)
Glottic Exposure Grade (Video LMA group)
Grade of glottic view (Grade 1-4) assessed via camera image in the video laryngeal mask group.
Measured: During device insertion (intraoperative)
Heart Rate
Heart rate (beats per minute) recorded before induction, after device placement, and during surgery.
Measured: Before induction (T0), after device placement (T1), and during surgery (T2)
Systolic Blood Pressure
Systolic blood pressure (mmHg) recorded before induction, after device placement, and during surgery.
Measured: Before induction (T0), after device placement (T1), and during surgery (T2)
Diastolic Blood Pressure
Diastolic blood pressure (mmHg) recorded before induction, after device placement, and during surgery.
Measured: Before induction (T0), after device placement (T1), and during surgery (T2)
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation (%) recorded before induction, after device placement, and during surgery.
Measured: Before induction (T0), after device placement (T1), and during surgery (T2)
Intraoperative Complications
Incidence of laryngospasm, bronchospasm, desaturation (SpO2 <90%), need for device repositioning, and need for conversion to endotracheal intubation.
Measured: Intraoperative period
Postoperative Sore Throat, Hoarseness, and Nausea/Vomiting
Presence or absence of sore throat, hoarseness, and nausea/vomiting assessed at 1 and 6 hours postoperatively.
Measured: Postoperative hour 1 (T3) and hour 6 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aysenur Kutluay, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Derya Karasu, Prof. Dr., Principal investigator, SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912619
- Sponsor's protocol ID
- BYIEAH-LMA-2026-01
- Other IDs
- 2026-9-9
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared, as no data-sharing plan has been established for this study beyond what is reported in the results of scientific publications.
Publications
Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29.
PubMed 36308611Bao D, Yu Y, Xiong W, Wang YX, Liang Y, Li L, Liu B, Jin X. Comparison of the clinical performance of i-gel and Ambu laryngeal masks in anaesthetised paediatric patients: A meta-analysis. World J Clin Cases. 2022 Feb 6;10(4):1242-1254. doi: 10.12998/wjcc.v10.i4.1242.
PubMed 35211557Selvin CC, Singariya G, Bihani P, Kamal M, Paliwal N, Ujwal S. Comparison of oropharyngeal leak pressure of I-gelTM and BlockbusterTM laryngeal mask airway in anaesthetized pediatric patients. Anesth Pain Med (Seoul). 2023 Jan;18(1):51-56. doi: 10.17085/apm.22209. Epub 2023 Jan 30.
PubMed 36746902Yan 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 34979936
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Second-Generation Laryngeal Mask Airway Versus Third-Generation Video Laryngeal Mask Airway on Airway Management in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07912619
- Acronym / sponsor ID
- BYIEAH-LMA-2026-01
- Conditions
- Airway Management, Anesthesia, General, Pediatric Anesthesia
- Keywords
- Laryngeal Mask, Video Laryngeal Mask, Supraglottic Airway, Oropharyngeal Leak Pressure, Pediatric, SafeLM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 Nov 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 study compares two airway devices used during general anesthesia in children: a second-generation laryngeal mask (SafeLM LMA) and a third-generation video laryngeal mask (SafeLM Video LMA). Both devices are CE-marked and routinely used in clinical practice. The study will include 90 children aged 2 to 8 years who are scheduled for elective surgery. Children will be randomly assigned to one of two groups (45 per group), and one of the two devices will be placed after anesthesia induction. The main outcome is oropharyngeal leak pressure, which shows how well the mask seals the airway. Other outcomes include success at the first insertion attempt, number of attempts, view of the vocal cords (video group), heart rate and blood pressure changes, and complications such as laryngospasm, low oxygen levels, sore throat, hoarseness, and nausea/vomiting. The study aims to show whether video-guided placement improves airway seal and safety in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second-Generation SafeLM LMA | Active comparator | Device: Second-Generation SafeLM LMAParticipants received a second-generation SafeLM laryngeal mask airway (LMA) after standard anesthesia induction, placed without using the video/camera component. |
| Third-Generation SafeLM Video LMA | Experimental | Device: Third-Generation SafeLM Video LMAParticipants received a third-generation SafeLM video laryngeal mask airway (LMA) after standard anesthesia induction, with the integrated camera system actively used to guide placement. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 2-8 years
- ASA physical status I-II
- Scheduled for elective surgery
- Expected surgical duration <90 minutes
- Written informed consent obtained from parent/guardian
Key exclusion criteria (12 listed)
- Obesity (BMI >95th percentile)
- Oropharyngeal or laryngeal pathology
- Coagulopathy or bleeding diathesis
- Parental/guardian refusal of consent
- Surgery requiring lateral or prone position
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 |
|---|---|---|
| Second-Generation SafeLM LMAA second-generation supraglottic airway device (SafeLM LMA) inserted after standard anesthesia induction to secure the airway. This device does not include a camera or video guidance component. | Device | Second-Generation SafeLM LMA |
| Third-Generation SafeLM Video LMAA third-generation video-guided supraglottic airway device (SafeLM Video LMA) inserted after standard anesthesia induction. The integrated adjustable camera provides real-time visualization to guide correct placement. | Device | Third-Generation SafeLM Video LMA |
Primary outcome
Oropharyngeal Leak Pressure (OLP)
Time frame: Measured immediately after device placement
Oropharyngeal leak pressure measured immediately after airway device placement, reflecting the sealing performance of the supraglottic airway.
9 secondary outcomes
First-Attempt Success Rate
Time frame: During device insertion (intraoperative)
Number of Insertion Attempts
Time frame: During device insertion (intraoperative)
Glottic Exposure Grade (Video LMA group)
Time frame: During device insertion (intraoperative)
Heart Rate
Time frame: Before induction (T0), after device placement (T1), and during surgery (T2)
Systolic Blood Pressure
Time frame: Before induction (T0), after device placement (T1), and during surgery (T2)
Diastolic Blood Pressure
Time frame: Before induction (T0), after device placement (T1), and during surgery (T2)
Peripheral Oxygen Saturation (SpO2)
Time frame: Before induction (T0), after device placement (T1), and during surgery (T2)
Intraoperative Complications
Time frame: Intraoperative period
Postoperative Sore Throat, Hoarseness, and Nausea/Vomiting
Time frame: Postoperative hour 1 (T3) and hour 6 (T4)
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 3 Nov 2026.
- Background: PubMed 36308611Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29.
- Background: PubMed 35211557Bao D, Yu Y, Xiong W, Wang YX, Liang Y, Li L, Liu B, Jin X. Comparison of the clinical performance of i-gel and Ambu laryngeal masks in anaesthetised paediatric patients: A meta-analysis. World J Clin Cases. 2022 Feb 6;10(4):1242-1254. doi: 10.12998/wjcc.v10.i4.1242.
- Background: PubMed 36746902Selvin CC, Singariya G, Bihani P, Kamal M, Paliwal N, Ujwal S. Comparison of oropharyngeal leak pressure of I-gelTM and BlockbusterTM laryngeal mask airway in anaesthetized pediatric patients. Anesth Pain Med (Seoul). 2023 Jan;18(1):51-56. doi: 10.17085/apm.22209. Epub 2023 Jan 30.
- 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared, as no data-sharing plan has been established for this study beyond what is reported in the results of scientific publications.
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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.
Derya Karasu, Prof. Dr. principal investigator
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second-Generation SafeLM LMA and Third-Generation SafeLM Video LMA in people with Airway Management and Anesthesia, General, run by Bursa Yuksek Ihtisas Training and Research 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 12 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 3 Nov 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?
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 Ayşenur Kutluay, Dr. (+905355556216, dr.aysenurylmz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal Leak Pressure (OLP) (time frame: Measured immediately after device placement). 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 NCT07912619, which also lists 4 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 3 Nov 2026.