An interventional study of SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in Airway Management, Shoulder Surgery and General Anesthetic, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
This study aims to compare the performance of SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in patients undergoing shoulder surgery in the beach chair position under general anesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. Secondary objectives include assessment of ventilation safety, need for airway interventions, and postoperative airway-related complications. This prospective randomized study will provide data on the effectiveness and safety of a video-guided supraglottic airway device compared to a conventional device in a clinically challenging position.
Shoulder surgery is frequently performed in the beach chair position (BCP), which may alter upper airway anatomy and increase the risk of airway-related complications. Changes in head and neck alignment, limited access to the airway due to surgical draping, and fluid extravasation during arthroscopy may negatively affect ventilation.
Supraglottic airway devices (SADs) are widely used in general anesthesia due to their ease of insertion and reduced invasiveness compared to endotracheal intubation. The i-gel® is a commonly used second-generation SAD with a non-inflatable cuff, while SafeLM™ is a video-guided laryngeal mask airway that allows real-time visualization of the glottic structures.
This prospective, randomized controlled study aims to compare SafeLM™ and i-gel® in patients undergoing shoulder surgery in the beach chair position. Patients aged 18-80 years with ASA physical status I-III will be randomly assigned to either the SafeLM™ or i-gel® group.
All patients will receive standardized anesthesia management, including induction with propofol and fentanyl and maintenance with sevoflurane. No neuromuscular blocking agents will be used. Following successful placement of the airway device, correct positioning will be confirmed by clinical and capnographic parameters.
The primary outcome of the study is the comparison of oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. OLP will be measured using a standardized technique with the adjustable pressure-limiting valve set to a maximum of 40 cmH2O.
Secondary outcomes include the incidence of ventilation impairment, need for airway interventions (such as jaw thrust, head repositioning, device adjustment or replacement), desaturation and hypercapnia episodes, first-attempt success rate, insertion time, and postoperative complications including sore throat, dysphonia, and postoperative nausea and vomiting.
In the SafeLM™ group, glottic visualization will be assessed using a standardized scoring system, and changes in glottic view associated with positional changes will be recorded.
This study aims to provide evidence on whether a video-guided supraglottic airway device offers advantages over a conventional device in maintaining airway stability and ventilation safety in the beach chair position.
Exclusion Criteria:
Participants randomized to this arm will receive airway management using the SafeLM™ video laryngeal mask airway during general anesthesia for shoulder surgery in the beach chair position.
Device: SafeLM™ video laryngeal mask airway
Participants randomized to this arm will receive airway management using the i-gel® supraglottic airway device during general anesthesia for shoulder surgery in the beach chair position.
Device: i-gel® supraglottic airway device
A video-guided supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position. It allows real-time visualization of glottic structures during placement.
A second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.
Oropharyngeal leak pressure (OLP) at two predefined time points: immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position
Comparison of oropharyngeal leak pressure (OLP) values measured immediately after insertion of the supraglottic airway device in the supine position and 5 minutes after transition to the beach chair position, as an indicator of airway sealing performance and ventilation safety.
Time frame: Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery
First-attempt success rate of supraglottic airway device placement
Successful placement of the supraglottic airway device on the first insertion attempt.
Time frame: Immediately after airway device placement during surgery
Number of attempts required for supraglottic airway device placement
Total number of insertion attempts required to achieve successful placement of the supraglottic airway device.
Time frame: Immediately after airway device placement during surgery
Ventilation safety and ventilation impairment events
Evaluation of ventilation safety based on the occurrence of ventilation impairment defined as SpO2 \<94%, ETCO2 ≥50 mmHg, increased peak airway pressure with decreased tidal volume or air leak, and need for airway interventions.
Time frame: From airway device insertion until the end of surgery
Airway trauma and blood staining on device
Presence of visible blood or signs of airway trauma on the supraglottic airway device after removal.
Time frame: Immediately after device removal at the end of surgery
Postoperative sore throat (VAS score) at early and late postoperative periods
Severity of postoperative sore throat assessed using a visual analog scale (VAS) continuously during the first 2 hours in the post-anesthesia care unit (PACU) and reassessed at 24 hours postoperatively in the ward.
Time frame: Continuously during the first 2 hours in the PACU and at 24 hours postoperatively in the ward
Mean arterial pressure
Mean arterial pressure recorded in the supine position before transition and at predefined time points after transition to the beach chair position (1, 5, and 10 minutes), as well as during a stable intraoperative period (approximately 30-40 minutes after positioning).
Time frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and during a stable intraoperative period (approximately 30-40 minutes after positioning)
Peak airway pressure (Ppeak)
Peak airway pressure recorded in the supine position before transition to the beach chair position and at predefined time points after positioning (1, 5, and 10 minutes), as well as during the stable intraoperative period.
Time frame: In the supine position before transition to the beach chair position, and at 1, 5, and 10 minutes after positioning, as well as during the stable intraoperative period
Postoperative nausea and vomiting (PONV) incidence at early and late postoperative periods
Incidence of postoperative nausea and vomiting (PONV) continuously assessed during the first 2 hours in the post-anesthesia care unit (PACU) and evaluated again at 24 hours after surgery.
Time frame: Continuously during the first 2 hours and at 24 hours postoperatively
Oxygen saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) recorded in the supine position before transition and at predefined time points after transition to the beach chair position (1, 5, and 10 minutes), as well as during a stable intraoperative period (approximately 30-40 minutes after positioning).
Time frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and during a stable intraoperative period (approximately 30-40 minutes after positioning)
Heart rate
Heart rate recorded in the supine position before transition and at predefined time points after transition to the beach chair position (1, 5, and 10 minutes), as well as during a stable intraoperative period (approximately 30-40 minutes after positioning).
Time frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and during a stable intraoperative period (approximately 30-40 minutes after positioning)
Tidal volume
Tidal volume recorded in the supine position before transition and at predefined time points after transition to the beach chair position (1, 5, and 10 minutes), as well as at approximately 30-40 minutes after positioning during surgery.
Time frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery
End-tidal carbon dioxide (EtCO₂)
End-tidal carbon dioxide (EtCO₂) values recorded in the supine position before transition and at predefined time points after transition to the beach chair position (1, 5, and 10 minutes), as well as at approximately 30-40 minutes after positioning during surgery.
Time frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery
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Ankara City Hospital Bilkent