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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SaCo VLMA airway management | Experimental | SaCo VLMA Supraglottic Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery |
|
| Other device for airway management | Active Comparator | Other Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| safety of use of SaCo VLM | complications ratio related to airway management in % | immediately after the surgery |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Gaszynski | Contact | 693462098 | +48 | tomasz.gaszynski@umed.lodz.pl |
| Paweł Ratajczyk | Contact | 693462098 | +48 | pawel.ratajczyk@umed.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Gaszynski | Medical University of Lodz | Principal Investigator |
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| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| D058109 | Airway Management |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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the collected data will be anonymized regarding used for airway control device
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D013812 | Therapeutics |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |