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Search / Trial NCT06602817

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

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Sep 16, 2024

Trial Information

Current as of May 28, 2025

Recruiting

Keywords

Prone Position Surgery Airway Management

ClinConnect Summary

This clinical trial is studying a new device called the I-gel Plus, which is used to help keep patients' airways open during surgery, especially when they are lying face down (in a prone position). While previous studies suggest that this device works well with few complications, there is still limited information about its effectiveness in this specific position. The main goal of the trial is to see how well the I-gel Plus maintains airflow in these patients and to compare its performance with data from patients who are lying on their backs (supine position).

To participate in this study, patients should be adults aged 18 to 89 who are scheduled for elective surgery while lying face down and will need this type of airway device. Those who are pregnant, breastfeeding, or have certain health conditions that might complicate the use of the device cannot participate. If chosen for the trial, participants can expect to have their breathing monitored closely during surgery, and the researchers will collect important data to help understand how well the I-gel Plus works in this setting. This study is currently recruiting participants, and it aims to contribute valuable information for future surgeries.

Gender

ALL

Eligibility criteria

  • 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

About Universitätsklinikum Hamburg Eppendorf

Universitätsklinikum Hamburg-Eppendorf (UKE) is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, UKE integrates state-of-the-art facilities with a multidisciplinary approach, fostering collaboration among top-tier researchers, clinicians, and healthcare professionals. The institution is dedicated to improving patient outcomes by conducting rigorous scientific investigations that address critical health challenges, ultimately contributing to the development of novel therapies and enhancing medical knowledge.

Locations

Hamburg, , Germany

Patients applied

0 patients applied

Trial Officials

Martin Petzoldt, MD

Principal Investigator

University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported