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NCT Number: NCT07501468

Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sündüz İlayda Yıldız Akça, MD

CONTACT

[email protected]

+905352501649

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SafeLM™ video laryngeal mask airway

Device

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 device

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 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

    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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sündüz İlayda Yıldız Akça, MD

CONTACT

[email protected]

+905076111649

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Acronym: SAFE-BCP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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