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Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures

ConditionsLaparoscopic Surgical ProceduresAirway ControlAnesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Lodz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: SaCo VLMA airway managementExperimental treatment 1 intervention
Group B: Other device for airway managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

effectiveness of use

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

Time frame
immediately after the intervention
2

effectiveness of mechanical ventilation

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

Time frame
perioperatively
3

safety of mechanical ventilation

providing adequate ventilation parameters - peak pressure in mmHg

Time frame
perioperatively
4

parameters of mechanical ventilation

measurement of lung compliance in ml/mmHg

Time frame
perioperatively

Secondary outcomes

1

safety of use of SaCo VLM

complications ratio related to airway management in %

Time frame
immediately after the surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Lodz

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: