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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-02-04

Brief Summary

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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.

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Detailed Description

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Conditions

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General Anesthesia Airway Management Supraglottic Airway

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery in prone position

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

Exposure: prone position

Intervention Type OTHER

Exposure: surgery in prone position

Surgery in supine position

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

Exposure: Supine position

Intervention Type OTHER

Exposure: Surgery in supine position

Interventions

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Exposure: prone position

Exposure: surgery in prone position

Intervention Type OTHER

Exposure: Supine position

Exposure: Surgery in supine position

Intervention Type OTHER

Eligibility Criteria

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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) \&gt;35 kg/m2
* Inability to understand or sign informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No