Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m²
Disqualifiers
Age <18 or >80 years
Refusal to participate
ASA physical status >= IV
BMI >40 kg/m²
Trial design
Design model
Parallel
Treatments tested in this trial
SafeLM™ video laryngeal mask airway
DeviceA 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.
i-gel® supraglottic airway device
DeviceA second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: SafeLM GroupExperimental treatment 1 intervention
Group B: i-gel GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgerySecondary outcomes
1
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 surgery2
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 surgeryOther outcomes
1
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 surgery2
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 surgery3
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 ward4
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)Sponsors and contacts
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Source ClinicalTrials.gov
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