I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Supraglottic Airway; Airway Management; General Anesthesia

Treatments: Other: Exposure: prone position; Other: Exposure: Supine position

Study type: Observational

Funder types: Other

Identifiers

NCT06602817

2024-101343-BO-ff

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

28 participants in 2 patient groups

Surgery in prone position

Description:

Patients undergoing elective surgery in prone position with i-gel Plus used for airway management

Treatment:

Other: Exposure: prone position

Surgery in supine position

Description:

Existing prospective control cohort with patients undergoing elective surgery in supine position with i-gel Plus used for airway management

Treatment:

Other: Exposure: Supine position