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Not yet recruiting NCT07391969

Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures

No phase Interventional Laparoscopic Surgical Procedures Airway Control Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SaCo VLM or SAD or ET for airway control for laparoscopy.
Who it may be relevant to
Registry conditions: Laparoscopic Surgical Procedures, Airway Control, Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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

Primary outcome measures

  • effectiveness of use [Time frame: immediately after the intervention]
  • effectiveness of mechanical ventilation [Time frame: perioperatively]
  • safety of mechanical ventilation [Time frame: perioperatively]
  • parameters of mechanical ventilation [Time frame: perioperatively]
Secondary outcome measures (1)
  • safety of use of SaCo VLM [Time frame: immediately after the surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07391969 · RNN/120/23/KE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗