I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Leak fraction
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Leak fraction
Time Frame: 3 houres
Ventilation parameter - volume per tidal volume
Secondary Outcomes
- Oropharyngeal seal pressure [cm H2O](3 houres)
- Leakage volume (ml)(3 houres)
- Tidal volume (ml)(3 houres)
- Inspiratory peak pressure (cm H2O)(3 houres)
- Positive endexpiratory pressure (PEEP) (cm H2O)(3 houres)
- Intraabdominal pressure under capnoperitoneum [mmHg](3 houres)
- Postoperative complications(24 hours postoperatively)
- Respiratory rate (1/min)(3 houres)
- Minute ventilation (l/min/kg)(3 houres)
- Endtidal CO2 [mmHg](3 houres)
- Number of insertion attempts(3 houres)
- Insertion success rate (%)(3 houres)
- First-attempt insertion success rate (%)(3 houres)
- Necessity of adjustment maneuvers during the procedure(3 houres)
- Insertion time (sec)(3 houres)
- Difficulty of insertion(3 houres)
- Ease of gastric tube insertion(3 houres)
- Lowest oxygen saturation (%)(3 houres)
- Complications at the end of surgery(3 hours)