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| Name | Class |
|---|---|
| Masimo Corporation | INDUSTRY |
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This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia. The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.
Sixty-two patients (ASA I-II, aged 18-65 years) scheduled for elective laparoscopic cholecystectomy were randomized into two groups: Group I (I-Gel) and Group P (LMA Protector). General anesthesia induction was standardized, and maintenance was provided with desflurane at a fresh gas flow of 1 L/min to achieve low-flow anesthesia. Peak inspiratory pressure (PIP), plateau pressure (Pplato), dynamic compliance (Cdyn), and airway resistance were recorded at six distinct intraoperative time points: 5 minutes after SGA insertion (T1), 1 minute after pneumoperitoneum insufflation (T2), 1 minute after the 30-degree reverse Trendelenburg position (T3), 10 minutes after insufflation (T4), 1 minute after desufflation (T5), and immediately before SGA removal (T6). Oropharyngeal leak pressure (OLP) was measured after insertion and before removal. Postoperative complications such as sore throat, cough, hoarseness, dysphagia, and nausea-vomiting were monitored postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: I-Gel | Experimental | Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy. |
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| Group P: LMA Protector | Experimental | Patients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-Gel supraglottic airway | Device | Placement of an appropriate size of i-gel supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia). |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Lung Compliance (Cdyn) | Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure). | Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Inspiratory Pressure (PIP) | Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia. | Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal. |
| Plateau Pressure (Pplateau) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fatih Sultan Mehmet Training and Research Hospital | Istanbul | 34752 | Turkey (Türkiye) |
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| LMA Protector supraglottic airway | Device | Placement of an appropriate size of LMA Protector supraglottic airway device for airway management during general anesthesia. Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia). |
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Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma. |
| Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal. |
| Airway Resistance | The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures. | Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal. |