Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel (SAFE-BCP)

March 26, 2026 updated by: semih başkan, Ankara City Hospital Bilkent

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SafeLM 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.
Device: 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 Comparator: i-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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time 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
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.
Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
First-attempt success rate of supraglottic airway device placement
Time Frame: Immediately after airway device placement during surgery
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
Time Frame: Immediately after airway device placement during surgery
Total number of insertion attempts required to achieve successful placement of the supraglottic airway device.
Immediately after airway device placement during surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ventilation safety and ventilation impairment events
Time Frame: From airway device insertion until the end of surgery
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.
From airway device insertion until the end of surgery
Airway trauma and blood staining on device
Time Frame: Immediately after device removal at the end of surgery
Presence of visible blood or signs of airway trauma on the supraglottic airway device after removal.
Immediately after device removal at the end of surgery
Postoperative sore throat (VAS score) at early and late postoperative periods
Time Frame: Continuously during the first 2 hours in the PACU and at 24 hours postoperatively in the ward
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.
Continuously during the first 2 hours in the PACU and at 24 hours postoperatively in the ward
Mean arterial pressure
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)
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).
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)
Peak airway pressure (Ppeak)
Time Frame: In the supine position before transition to the beach chair position, and at 1, 5, and 10 minutes after positioning, as well as during the stable intraoperative period
Peak airway pressure recorded in the supine position before transition to the beach chair position and at predefined time points after positioning (1, 5, and 10 minutes), as well as during the stable intraoperative period.
In the supine position before transition to the beach chair position, and at 1, 5, and 10 minutes after positioning, as well as during the stable intraoperative period
Postoperative nausea and vomiting (PONV) incidence at early and late postoperative periods
Time Frame: Continuously during the first 2 hours and at 24 hours postoperatively
Incidence of postoperative nausea and vomiting (PONV) continuously assessed during the first 2 hours in the post-anesthesia care unit (PACU) and evaluated again at 24 hours after surgery.
Continuously during the first 2 hours and at 24 hours postoperatively
Oxygen saturation (SpO₂)
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)
Peripheral oxygen saturation (SpO₂) 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).
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)
Heart rate
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)
Heart rate 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).
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)
Tidal volume
Time Frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery
Tidal volume 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 at approximately 30-40 minutes after positioning during surgery.
In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery
End-tidal carbon dioxide (EtCO₂)
Time Frame: In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery
End-tidal carbon dioxide (EtCO₂) values 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 at approximately 30-40 minutes after positioning during surgery.
In the supine position before transition and at 1, 5, and 10 minutes after transition to the beach chair position, and at approximately 30-40 minutes after positioning during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-OMUZ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Airway Management

Clinical Trials on SafeLM™ video laryngeal mask airway

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings