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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07391969
Enrollment
20
Registered
2026-02-06
Start date
2026-02-01
Completion date
2027-03-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Control, Anesthesia, Laparoscopic Surgical Procedures

Brief 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.

Interventions

DEVICESaCo VLM or SAD or ET for airway control for laparoscopy

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

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

the collected data will be anonymized regarding used for airway control device

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
effectiveness of useimmediately after the interventionsuccess ratio of insertion of SGA or ET in % of success insertion
effectiveness of mechanical ventilationperioperativelyadequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml
safety of mechanical ventilationperioperativelyproviding adequate ventilation parameters - peak pressure in mmHg
parameters of mechanical ventilationperioperativelymeasurement of lung compliance in ml/mmHg

Secondary

MeasureTime frameDescription
safety of use of SaCo VLMimmediately after the surgerycomplications ratio related to airway management in %

Contacts

CONTACTTomasz Gaszynski
tomasz.gaszynski@umed.lodz.pl693462098
CONTACTPaweł Ratajczyk
pawel.ratajczyk@umed.lodz.pl693462098
PRINCIPAL_INVESTIGATORTomasz Gaszynski

Medical University of Lodz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026