NCT07391969

Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures

Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison with other airway management methods including other supraglottic devices. The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.

Detailed description

Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison of other supraglottic devices and other methods of airway management for such procedures. The airway management for laparoscopic surgery can be achieved by either endotracheal intubation (ET) or use of supraglottic devices (SGA). However, many anesthesiologist still prefer ET over use of SGA because of possible problems with adequate ventilation during pneumoperitoneum. New SGA devices as video laryngeal mask offer important advantage which is continuous control of proper placement of SGA during anesthesia. In case of ventilation difficulties like leak, high peak pressure, low tidal volume SGA VLM allow to check if the problem is related to malposition or changed of position of SGA and allow for correction under control of vision. The aim of this study is to evaluate the characteristics of the SaCo VLMA video laryngeal mask in the hands of experienced anesthesiologists. All patients will be anesthetized following the same protocol: Intravenous induction with propofol, FNT, midazolam, rocuronium in standard doses. After achieving proper muscle relaxation SaCo VLMA was inserted following manufacturer recommendations. For maintaining anesthesia sevoflurane was used. After induction for anesthesia the airway of the patient will be secured by one randomly chosen device: SaCo VLMA or other SGA or ET. The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.

Conditions

• Laparoscopic Surgical Procedures
• Airway Control
• Anesthesia

Interventions

Type	Name	Description
DEVICE	SaCo VLM or SAD or ET for airway control for laparoscopy	Evaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2026-02-06
• Last updated: 2026-02-06