Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
調査の概要
状態
詳細な説明
Laparoscopic surgery requires the creation of pneumoperitoneum and frequently involves patient positioning changes, both of which can increase intrathoracic and airway pressures. These physiological changes may affect the performance of supraglottic airway devices and challenge effective ventilation.
Second-generation supraglottic airway devices are increasingly used as alternatives to endotracheal intubation in laparoscopic procedures because they provide effective ventilation while reducing airway-related complications. The i-gel is widely used due to its ease of insertion, integrated gastric drainage channel, and favorable safety profile. The SaCoVLM (Video Laryngeal Mask) is a novel supraglottic airway device that enables direct visualization of laryngeal structures during placement, allowing confirmation of optimal positioning and potentially improving airway management.
This prospective observational study will compare the i-gel and SaCoVLM in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Ventilation performance, airway sealing pressure, insertion success, ease of placement, hemodynamic responses, and perioperative airway-related complications will be assessed. The findings may provide further evidence regarding the clinical performance and safety of these devices during laparoscopic surgery.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Hatice Selçuk Kuşderci
- 電話番号：505 215 98 96
- メール：drkusderci@hotmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age between 18 and 70 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for elective laparoscopic cholecystectomy.
- Patients undergoing general anesthesia.
- Patients who provide written informed consent.
Exclusion Criteria:
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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Group I: i-gel group
Patients receiving airway management with the i-gel supraglottic airway device
|
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Grup II: SaCoVLM
Patients receiving airway management with the SaCoVLM supraglottic airway device
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
時間枠：After device insertion and after pneumoperitoneum creation during surgery.
|
Oropharyngeal leak pressure (OLP) will be measured and compared between the i-gel and SaCoVLM groups to evaluate airway sealing performance during elective laparoscopic cholecystectomy..
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After device insertion and after pneumoperitoneum creation during surgery.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First-Attempt Insertion Success Rate
時間枠：During device insertion procedure
|
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
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During device insertion procedure
|
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Device Insertion Time
時間枠：During device insertion procedure
|
The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.
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During device insertion procedure
|
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Gastric Tube Insertion Success Rate
時間枠：Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
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The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.
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Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
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Peak Airway Pressure (PAP)
時間枠：5 minutes after pneumoperitoneum is established.
|
Peak airway pressure values measured during mechanical ventilation and compared between study groups
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5 minutes after pneumoperitoneum is established.
|
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End-Tidal Carbon Dioxide (EtCO₂)
時間枠：Throughout laparoscopic surgery.
|
End-tidal carbon dioxide values measured during surgery and compared between study groups.
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Throughout laparoscopic surgery.
|
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Postoperative Sore Throat
時間枠：Within 24 hours after surgery.
|
The incidence of postoperative sore throat following removal of the supraglottic airway device.Postoperative sore throat severity assessed using an 11-point Numeric Rating Scale (NRS)
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Within 24 hours after surgery.
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Hoarseness
時間枠：Within 24 hours after surgery.
|
The incidence of postoperative dysphagia following airway device use.
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Within 24 hours after surgery.
|
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Blood Staining and Mucosal Trauma
時間枠：Immediately after device removal.
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The incidence of blood staining on the device and evidence of mucosal trauma after device removal.
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Immediately after device removal.
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Hemodynamic Parameters
時間枠：Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
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Heart rate (beats per minute [bpm]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean heart rate values will be compared between the i-gel and SaCoVLM groups.Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean systolic blood pressure values will be compared between the i-gel and SaCoVLM groups.Mean arterial pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Mean arterial pressure values will be
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Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Hatice Selçuk Kuşderci、Samsun University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- GOKAEK 2026/11/18
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