Airway Management, General Anesthetic, Shoulder Surgery, Supraglottic Airway
Conditions
Keywords
Oropharyngeal Leak Pressure, SafeLM, i-gel, Ventilation Safety, Beach Chair Position, Video Laryngeal Mask Airway
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.
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.
Interventions
DEVICESafeLM™ 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.
DEVICEi-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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt success rate of supraglottic airway device placement | Immediately after airway device placement during surgery | Successful placement of the supraglottic airway device on the first insertion attempt. |
| Number of attempts required for supraglottic airway device placement | Immediately after airway device placement during surgery | Total number of insertion attempts required to achieve successful placement of the supraglottic airway device. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSündüz İlayda Yıldız Akça, MD
Outcome results
None listed