SaCo VLM or SAD or ET for airway control for laparoscopy
DeviceEvaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures
NCT Number: NCT07391969
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures
Time frame: immediately after the intervention
success ratio of insertion of SGA or ET in % of success insertion
Time frame: perioperatively
adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml
Time frame: perioperatively
providing adequate ventilation parameters - peak pressure in mmHg
Time frame: perioperatively
measurement of lung compliance in ml/mmHg
Time frame: immediately after the surgery
complications ratio related to airway management in %
Contact information is provided by the study sponsor or research team.
Medical University of Lodz
Other
Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures
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