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Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy

17 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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:

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Oropharyngeal Leak Pressure (OLP)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
First-Attempt Insertion Success Rate
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: Throughout laparoscopic surgery.
End-tidal carbon dioxide values measured during surgery and compared between study groups.
Throughout laparoscopic surgery.
Postoperative Sore Throat
Tidsram: 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
Tidsram: Within 24 hours after surgery.
The incidence of postoperative dysphagia following airway device use.
Within 24 hours after surgery.
Blood Staining and Mucosal Trauma
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Samsun University

Utredare

  • Studierektor: Hatice Selçuk Kuşderci, Samsun University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

24 juni 2026

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

24 juni 2026

Först inskickad som uppfyllde QC-kriterierna

2 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • GOKAEK 2026/11/18

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