Airway ManagementSAFE-BCPNCT07501468
Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel
A study testing SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in people with Airway Management and Shoulder Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Management, Shoulder Surgery, General Anesthetic
- What is being tested?
- SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
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
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.
Read the 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.
- Being tested
- SafeLM™ video laryngeal mask airway, i-gel® supraglottic airway device
- Keywords
- Oropharyngeal Leak Pressure, SafeLM, i-gel, Ventilation Safety, Beach Chair Position, Video Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeLM™ video laryngeal mask airwayDevice
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.
i-gel® supraglottic airway deviceDevice
A second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: i-gel® supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Successful placement of the supraglottic airway device on the first insertion attempt.
Measured: 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.
Measured: Immediately after airway device placement during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Apr 2026
- Primary completion15 Aug 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, semih başkan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501468
- Sponsor's protocol ID
- 2025-OMUZ-01
- Acronym
- SAFE-BCP
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07501468
- Acronym / sponsor ID
- SAFE-BCP / 2025-OMUZ-01
- Keywords
- Oropharyngeal Leak Pressure, SafeLM, i-gel, Ventilation Safety, Beach Chair Position, Video Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 16 Aug 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SafeLM Group | Experimental | Device: SafeLM™ video laryngeal mask airwayParticipants 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. |
| i-gel Group | Active comparator | Device: i-gel® supraglottic airway deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeLM™ video laryngeal mask airwayA 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. | Device | SafeLM Group |
| i-gel® supraglottic airway deviceA second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position. | Device | i-gel Group |
Primary outcome
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
Time frame: 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.
2 secondary outcomes
First-attempt success rate of supraglottic airway device placement
Time frame: Immediately after airway device placement during surgery
Number of attempts required for supraglottic airway device placement
Time frame: Immediately after airway device placement during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in people with Airway Management and Shoulder Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.