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NCT Number: NCT07391969

Evaluation of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SaCo VLM or SAD or ET for airway control for laparoscopy

Device

Evaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures

Primary outcomes

  1. effectiveness of use

    Time frame: immediately after the intervention

    success ratio of insertion of SGA or ET in % of success insertion

  2. effectiveness of mechanical ventilation

    Time frame: perioperatively

    adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml

  3. safety of mechanical ventilation

    Time frame: perioperatively

    providing adequate ventilation parameters - peak pressure in mmHg

  4. parameters of mechanical ventilation

    Time frame: perioperatively

    measurement of lung compliance in ml/mmHg

Secondary outcomes

  1. safety of use of SaCo VLM

    Time frame: immediately after the surgery

    complications ratio related to airway management in %

Study contacts

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

Paweł Ratajczyk

CONTACT

[email protected]

693462098 ext. +48

Tomasz Gaszynski

CONTACT

[email protected]

693462098 ext. +48

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 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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