Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel

NCT07501468 | Not Yet Recruiting

• 1 other identifier: 2025-OMUZ-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management; Shoulder Surgery; General Anesthetic; Supraglottic Airway

Keywords

Oropharyngeal Leak Pressure; SafeLM; i-gel; Ventilation Safety; Beach Chair Position; Video Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• First-attempt success rate of supraglottic airway device placement

  Immediately after airway device placement during surgery

• Number of attempts required for supraglottic airway device placement

  Immediately after airway device placement during surgery

Other Outcomes (10)

• Ventilation safety and ventilation impairment events

  From airway device insertion until the end of surgery

• Airway trauma and blood staining on device

  Immediately after device removal at the end of surgery

• Postoperative sore throat (VAS score) at early and late postoperative periods

  Continuously during the first 2 hours in the PACU and at 24 hours postoperatively in the ward

Study Arms (2)

SafeLM Group

EXPERIMENTAL

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

i-gel Group

ACTIVE COMPARATOR

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

Interventions

SafeLM™ video laryngeal mask 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.

SafeLM Group

i-gel® supraglottic airway device DEVICE

A second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.

i-gel Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Central Study Contacts

Sündüz İlayda Yıldız Akça, MD

CONTACT

+905076111649; sunduzilayda@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the SafeLM™ video laryngeal mask airway group or the i-gel® supraglottic airway device group. Both groups will be managed under standardized anesthesia protocols, and outcomes will be compared between parallel groups.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)