I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position
- Conditions
- General AnesthesiaAirway ManagementSupraglottic Airway
- Registration Number
- NCT06602817
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position.
The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- Patients scheduling for elective surgery in prone position
- Planned airway management using a SGA
- Adult patients (age 18-89 years)
- ASA physical status 1-3
- Pregnant or breastfeeding women
- Non-fasted patients
- Increased risk of aspiration or other contraindications for supraglottic mask ventilation
- Shared airway or intracavity open surgery
- 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 hours Ventilation parameter - Leakage volume per tidal volume
- Secondary Outcome Measures
Name Time Method Oropharyngeal seal pressure [cm H2O] 3 hours Clinical assessment - leak pressure with audible leak
Leakage volume (ml) 3 hours Ventilation parameter - as displayed on the ventilator
Minute ventilation (l/min/kg) 3 hours Ventilation parameter -as displayed on the ventilator
Tidal volume (ml) 3 hours Ventilation parameter - as displayed on the ventilator
Inspiratory peak pressure (cm H2O) 3 hours Ventilation parameter - as displayed on the ventilator
Positive endexpiratory pressure (PEEP) (cm H2O) 3 hours Ventilation parameter - as displayed on the ventilator
Respiratory rate (1/min) 3 hours Ventilation parameter - as displayed on the ventilator
Endtidal CO2 [mmHg] 3 hours Ventilation parameter - as displayed on the ventilator
Number of insertion attempts 3 hours Clinical assessment - SGA insertion attempts
Insertion success rate (%) 3 hours Clinical assessment
First-attempt insertion success rate (%) 3 hours Clinical assessment - successful placement in only one insertion attempt
Necessity of adjustment maneuvers during the procedure 3 hours Clinical assessment
Insertion time (sec) 3 hours Clinical assessment
Lowest oxygen saturation (%) 3 hours Measured by pulse oximetry
Postoperative complications 24 hours postoperatively Clinical assessment
Difficulty of insertion 3 hours Clinical assessment on a scale between 1-5
Ease of gastric tube insertion 3 hours Clinical assessment - rating on a scale from 1-5
Complications at the end of surgery 3 hours Clinical assessment
Trial Locations
- Locations (1)
University Medical-Center Hamburg Eppendorf
🇩🇪Hamburg, Germany
University Medical-Center Hamburg Eppendorf🇩🇪Hamburg, GermanyMartin Petzoldt, MDContactm.petzoldt@uke.de004940741052415Nils Meiswinkel, MDContactn.meiswinkel@uke.de004940741052415