An interventional study of SaCo VLM or SAD or ET for airway control for laparoscopy in Laparoscopic Surgical Procedures, Airway Control and Anesthesia, sponsored by Medical University of Lodz. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Other
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.
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.
Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Present risk factors for bronchial aspiration
- Presenting with preoperative sore throat
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Evaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures
effectiveness of use
success ratio of insertion of SGA or ET in % of success insertion
Time frame: immediately after the intervention
effectiveness of mechanical ventilation
adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml
Time frame: perioperatively
safety of mechanical ventilation
providing adequate ventilation parameters - peak pressure in mmHg
Time frame: perioperatively
parameters of mechanical ventilation
measurement of lung compliance in ml/mmHg
Time frame: perioperatively
safety of use of SaCo VLM
complications ratio related to airway management in %
Time frame: immediately after the surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jan 2027, 11 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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