Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
17. Juli 2026 aktualisiert von: Samsun University
Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
This prospective observational study aims to compare the ventilation performance and safety of the i-gel and SaCoVLM supraglottic airway devices in adult patients undergoing elective laparoscopic cholecystectomy.
Ventilation-related parameters, airway sealing performance, insertion characteristics, and perioperative complications will be evaluated.
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
80
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Hatice Selçuk Kuşderci
- Telefonnummer: 505 215 98 96
- E-Mail: drkusderci@hotmail.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
The study population will consist of adult patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia at Samsun City Hospital.
Eligible patients who provide written informed consent and meet the study inclusion criteria will be consecutively enrolled during the study period.
Beschreibung
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:
-
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Group I: i-gel group
Patients receiving airway management with the i-gel supraglottic airway device
|
|
Grup II: SaCoVLM
Patients receiving airway management with the SaCoVLM supraglottic airway device
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
Zeitfenster: 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..
|
After device insertion and after pneumoperitoneum creation during surgery.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
First-Attempt Insertion Success Rate
Zeitfenster: During device insertion procedure
|
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
|
During device insertion procedure
|
|
Device Insertion Time
Zeitfenster: 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.
|
During device insertion procedure
|
|
Gastric Tube Insertion Success Rate
Zeitfenster: Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
|
The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.
|
Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
|
|
Peak Airway Pressure (PAP)
Zeitfenster: 5 minutes after pneumoperitoneum is established.
|
Peak airway pressure values measured during mechanical ventilation and compared between study groups
|
5 minutes after pneumoperitoneum is established.
|
|
End-Tidal Carbon Dioxide (EtCO₂)
Zeitfenster: Throughout laparoscopic surgery.
|
End-tidal carbon dioxide values measured during surgery and compared between study groups.
|
Throughout laparoscopic surgery.
|
|
Postoperative Sore Throat
Zeitfenster: 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)
|
Within 24 hours after surgery.
|
|
Hoarseness
Zeitfenster: Within 24 hours after surgery.
|
The incidence of postoperative dysphagia following airway device use.
|
Within 24 hours after surgery.
|
|
Blood Staining and Mucosal Trauma
Zeitfenster: Immediately after device removal.
|
The incidence of blood staining on the device and evidence of mucosal trauma after device removal.
|
Immediately after device removal.
|
|
Hemodynamic Parameters
Zeitfenster: Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
|
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
|
Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Hatice Selçuk Kuşderci, Samsun University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
24. Juni 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2026
Studienabschluss (Geschätzt)
31. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
24. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Juli 2026
Zuerst gepostet (Tatsächlich)
9. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- GOKAEK 2026/11/18
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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