Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Laparoscopic Surgical Procedures; Airway Control
• Intervention / Treatment: Device: SaCo VLM or SAD or ET for airway control for laparoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Gaszynski; Phone Number: +48 693462098; Email: tomasz.gaszynski@umed.lodz.pl
• Study Contact Backup: Name: Paweł Ratajczyk; Phone Number: +48 693462098; Email: pawel.ratajczyk@umed.lodz.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing elective surgery under general anesthesia for laparoscopic surgery of predicting lasting no longer than about 1 hour.
• Age >18 years.
• ASA I-III.
• Present ordinary airway

Exclusion Criteria:

• Not meeting the above criteria
• Presenting 3 predictors of a difficult airway (Mallampatti class III or IV; thyromental distance <6 cm, sternomental distance <12.5 cm, distance between incisors <4.0 cm, bite test II or III, cervical mobility <90o).
• Gestation
• Allergy to any drug included in the protocol.

• Present risk factors for bronchial aspiration

  - Presenting with preoperative sore throat

• Present severe respiratory, coronary or cerebral vascular pathology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SaCo VLMA airway management; SaCo VLMA Supraglottic Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery	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
Active Comparator: Other device for airway management; Other Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of use	success ratio of insertion of SGA or ET in % of success insertion	immediately after the intervention
effectiveness of mechanical ventilation	adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml	perioperatively
safety of mechanical ventilation	providing adequate ventilation parameters - peak pressure in mmHg	perioperatively
parameters of mechanical ventilation	measurement of lung compliance in ml/mmHg	perioperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of use of SaCo VLM	complications ratio related to airway management in %	immediately after the surgery

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Principal Investigator: Tomasz Gaszynski, Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Physiological Phenomena; Diagnostic Techniques, Surgical; Endoscopy; Physical Examination; Body Size; Body Weights and Measures; Body Constitution; Anthropometry; Laparoscopy; Sagittal Abdominal Diameter; Airway Management
• Other Study ID Numbers: RNN/120/23/KE

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