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Clinical Trial NCT07501468 (SAFE-BCP) for Airway Management, Shoulder Surgery, General Anesthetic, Supraglottic Airway is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel (SAFE-BCP) 70 Randomized

Not yet recruiting
Clinical Trial NCT07501468 (SAFE-BCP) is an interventional study for Airway Management, Shoulder Surgery, General Anesthetic, Supraglottic Airway and is currently not yet recruiting. Enrollment is planned to begin on April 15, 2026 and continue until the study accrues 70 participants. Led by Ankara City Hospital Bilkent, this study is expected to complete by September 15, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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...Show More
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 the...

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Official Title

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

Conditions
Airway ManagementShoulder SurgeryGeneral AnestheticSupraglottic Airway
Other Study IDs
  • SAFE-BCP
  • 2025-OMUZ-01
NCT ID Number
NCT07501468
Start Date (Actual)
2026-04-15
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-09-15
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Oropharyngeal Leak Pressure
SafeLM
i-gel
Ventilation Safety
Beach Chair Position
Video Laryngeal Mask Airway
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSafeLM 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.
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 Comparatori-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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Ankara City Hospital Bilkent logoAnkara City Hospital Bilkent
Study Responsible Party
semih başkan, Principal Investigator, Principal Investigator, Ankara City Hospital Bilkent
Study Central Contact
Contact: Sündüz İlayda Yıldız Akça, MD, +905076111649, [email protected]
1 Study Locations in 1 Countries

Ankara

Ankara Bilkent City Hospital, Ankara, Ankara, 06800, Turkey (Türkiye)
Sündüz İlayda Yıldız Akça, MD, Contact, +905352501649, [email protected]