I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

Recruiting

• Conditions: Airway Management; Supraglottic Airway; General Anesthesia; Laparoscopic Surgery

• Registration Number: NCT06602830
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

i-gel Plus is a novel supraglottic airway device (SGA). Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies. During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia, and higher inspiratory peak pressures have to be expected. It is uncertain, however, if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery.

The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum (with and without Trendelenburg position) and to compare it with baseline conditions. Secondary aims are to assess secondary outcome parameters during capnoperitoneum (with and without Trendelenburg position) and to compare them with baseline conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients scheduling for elective laparoscopic surgery
• Planned airway management using a SGA
• Adult patients (age 18-89 years)
• ASA physical status 1-3

Exclusion Criteria

• Pregnant or breastfeeding women
• Non-fasted patients
• Increased risk of aspiration or other contraindications for supraglottic mask ventilation
• Body mass index (BMI) >35 kg/m2
• Inability to understand or sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Leak fraction	3 houres	Ventilation parameter - volume per tidal volume

Secondary Outcome Measures

Name	Time	Method
Oropharyngeal seal pressure [cm H2O]	3 houres	Clinical assessment - leak pressure with audible leak
Leakage volume (ml)	3 houres	Ventilation parameter - as displayed on the ventilator
Tidal volume (ml)	3 houres	Ventilation parameter - as displayed on the ventilator
Inspiratory peak pressure (cm H2O)	3 houres	Ventilation parameter - as displayed on the ventilator
Positive endexpiratory pressure (PEEP) (cm H2O)	3 houres	Ventilation parameter - as displayed on the ventilator
Intraabdominal pressure under capnoperitoneum [mmHg]	3 houres	Measured intraoperativ under capnoperitoneum \[mmHg\]
Respiratory rate (1/min)	3 houres	Ventilation parameter - as displayed on the ventilator
Minute ventilation (l/min/kg)	3 houres	Ventilation parameter - as displayed on the ventilator
Endtidal CO2 [mmHg]	3 houres	Ventilation parameter - as displayed on the ventilator
Number of insertion attempts	3 houres	Clinical assessment - SGA insertion attempts
Insertion success rate (%)	3 houres	Clinical assessment
First-attempt insertion success rate (%)	3 houres	Clinical assessment - successful placement in only one insertion attempt
Necessity of adjustment maneuvers during the procedure	3 houres	Clinical assessment
Insertion time (sec)	3 houres	Clinical assessment
Difficulty of insertion	3 houres	Clinical assessment on a scale between 1-5
Ease of gastric tube insertion	3 houres	Clinical assessment - rating on a scale from 1-5
Lowest oxygen saturation (%)	3 houres	Measured by pulse oximetry
Postoperative complications	24 hours postoperatively	Clinical assessment
Complications at the end of surgery	3 hours	Clinical assessment

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany