Recruiting NCT06938308
Comparison Between the I-gel and Protector Supraglottic Airway Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LMA Igel, LMA Protector.
- Who it may be relevant to
- Registry conditions: Airway Management, Learning Curve. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between the I-gel and Protector Supraglottic Airway Devices in Patients Under General Anesthesia
Overview
This study aims to compare the learning curves of two different laryngeal mask airway devices, by evaluating their placement in adult patients performed by anesthesiology residents
Interventions
- Device LMA Igel
adults allocated to the LMA Igel group, an LMA Igel device will be inserted intraoperatively - Device LMA Protector
adults allocated to the LMA Protector group, an LMA Protector device will be inserted intraoperatively
Primary outcome measures
- The time required for successful placement of the device [Time frame: Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed]
Secondary outcome measures (1)
- Documentation of adverse events during placement [Time frame: During the placement attempt]
Eligibility criteria
Inclusion criteria
- ASA I-II
- Patients older than 18 years
- Procedures in supine and lithotomy position
Exclusion criteria
- Tumors or anatomical anomalies of the upper airway
- Known history of difficult intubation
- Limited mouth opening less than 2cm
- Decreased compliance of the lungs or the thoracic cage
- Need of mechanical ventilation after the surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Greece · 1 center
- SismanoglioGH — Athens
Identifiers
NCT: NCT06938308 · 9254/10-04-2025