Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel (SAFE-BCP)

Comparison of SafeLM™ Video Laryngeal Mask and I-gel® for Ventilation Safety After Transition to Beach Chair Position in Patients Undergoing Shoulder Surgery: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management; Shoulder Surgery; Supraglottic Airway; General Anesthetic
• Intervention / Treatment: Device: SafeLM™ video laryngeal mask airway; Device: i-gel® supraglottic airway device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sündüz İlayda Yıldız Akça, MD; Phone Number: +905076111649; Email: sunduzilayda@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06800
      • Ankara Bilkent City Hospital
      • Contact: Sündüz İlayda Yıldız Akça, MD; Phone Number: +905352501649; Email: sunduzilayda@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-80 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective shoulder surgery
• Body mass index (BMI) between 18-40 kg/m^2
• Adequate preoperative fasting (approximately 8 hours)
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• Age <18 or >80 years
• Refusal to participate
• ASA physical status >= IV
• BMI >40 kg/m^2
• Failure of supraglottic airway device placement after three attempts
• Revision surgery
• Multiple trauma
• Maxillofacial fracture
• Active malignancy receiving radiotherapy or chemotherapy
• Active infection or ongoing antibiotic therapy (except prophylaxis)
• Chronic steroid or immunosuppressive therapy
• Full stomach
• Gastroesophageal reflux disease
• History of gastric surgery
• Gastroparesis
• Known egg allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SafeLM Group; 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; 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.
Active Comparator: i-gel Group; 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 second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt success rate of supraglottic airway device placement	Successful placement of the supraglottic airway device on the first insertion attempt.	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.	Immediately after airway device placement during surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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).	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).	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.	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.	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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: i-gel; Video Laryngeal Mask Airway; Oropharyngeal Leak Pressure; SafeLM; Ventilation Safety; Beach Chair Position
• Other Study ID Numbers: 2025-OMUZ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No