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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamburg, , Germany
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