Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
17 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
80
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hatice Selçuk Kuşderci
- Numéro de téléphone: 505 215 98 96
- E-mail: drkusderci@hotmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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:
-
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
First-Attempt Insertion Success Rate
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: Throughout laparoscopic surgery.
|
End-tidal carbon dioxide values measured during surgery and compared between study groups.
|
Throughout laparoscopic surgery.
|
|
Postoperative Sore Throat
Délai: 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
Délai: Within 24 hours after surgery.
|
The incidence of postoperative dysphagia following airway device use.
|
Within 24 hours after surgery.
|
|
Blood Staining and Mucosal Trauma
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Hatice Selçuk Kuşderci, Samsun University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
24 juin 2026
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
24 juin 2026
Première soumission répondant aux critères de contrôle qualité
2 juillet 2026
Première publication (Réel)
9 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GOKAEK 2026/11/18
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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