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

NCT06602817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • General Anesthesia
  • Airway Management
  • Supraglottic Airway

Interventions

OTHER

Exposure: prone position

Exposure: surgery in prone position

OTHER

Exposure: Supine position

Exposure: Surgery in supine position

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Martin Petzoldt, MD · University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-02-04
Completion
2025-02-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602817 on ClinicalTrials.gov