NCT07391969

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 2, 2026

Last Update Submit

February 2, 2026

Conditions

Laparoscopic Surgical ProceduresAirway ControlAnesthesia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • safety of use of SaCo VLM

    immediately after the surgery

Study Arms (2)

SaCo VLMA airway management

EXPERIMENTAL

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

Other device for airway management

ACTIVE COMPARATOR

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

Interventions

SaCo VLM or SAD or ET for airway control for laparoscopyDEVICE

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

Other device for airway managementSaCo VLMA airway management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sagittal Abdominal DiameterAirway ManagementLaparoscopy

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaTherapeuticsEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Tomasz Gaszynski

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Gaszynski

CONTACT

693462098tomasz.gaszynski@umed.lodz.pl

Paweł Ratajczyk

CONTACT

693462098pawel.ratajczyk@umed.lodz.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the collected data will be anonymized regarding used for airway control device
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr hab.

Study Record Dates

First Submitted

January 2, 2026

First Posted

February 6, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share