An interventional study of Second-Generation SafeLM LMA and Third-Generation SafeLM Video LMA in Airway Management, Anesthesia, General and Pediatric Anesthesia, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Other
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.
Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received a second-generation SafeLM laryngeal mask airway (LMA) after standard anesthesia induction, placed without using the video/camera component.
Device: Second-Generation SafeLM LMA
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.
Device: Third-Generation SafeLM Video LMA
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.
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.
Oropharyngeal Leak Pressure (OLP)
Oropharyngeal leak pressure measured immediately after airway device placement, reflecting the sealing performance of the supraglottic airway.
Time frame: Measured immediately after device placement
First-Attempt Success Rate
Proportion of participants in whom the airway device was successfully placed on the first insertion attempt.
Time frame: During device insertion (intraoperative)
Number of Insertion Attempts
Total number of attempts required to successfully place the airway device.
Time frame: 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.
Time frame: During device insertion (intraoperative)
Heart Rate
Heart rate (beats per minute) recorded before induction, after device placement, and during surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative hour 1 (T3) and hour 6 (T4)
Device Insertion Time
Time (in seconds) required to successfully insert the airway device.
Time frame: During device insertion (intraoperative)
Inspired and Expired Tidal Volume
Inspired and expired tidal volume (mL) recorded during surgery.
Time frame: During surgery (T2)
Minute Ventilation Leak Rate
Minute ventilation leak rate (%) recorded during surgery.
Time frame: During surgery (T2)
Peak Airway Pressure
Peak airway pressure (cmH2O) recorded during surgery.
Time frame: During surgery (T2)
Blood on Device After Removal
Presence or absence of visible blood on the airway device following its removal.
Time frame: At the end of surgery, upon device removal
Induction-to-Incision Time, Total Anesthesia Duration, and Recovery Time
Time from anesthesia induction to surgical incision, total duration of anesthesia, and time to recovery, all recorded in minutes.
Time frame: Throughout the perioperative period
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bursa Yuksek Ihtisas Training and Research Hospital