Clinical trial NCT06825910: LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients
Official title: Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Management
General Anesthesia
Keywords: LMA
Protector
Airway Device Evaluation
iGel
Airway Device Comparison
Lead sponsor: Sismanoglio General Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

Detailed description: This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

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

Primary outcomes:
measure: Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions
timeFrame: Leak pressure will be measured in cmH2O within 60 seconds after successful placement: first in the neutral position, second in the extended position, and third in the extended rotated head position
Secondary outcomes:
measure: Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index
timeFrame: The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation
measure: The time required for successful placement of the device
timeFrame: 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
measure: Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask
timeFrame: Each attempt, from the moment the clinician picks up the nasogastric tube, will have a time frame of 5 seconds. If the nasogastric tube is not placed within 5 seconds, the attempt will be considered a failure
measure: Documentation of adverse events after the exertion
timeFrame: Immediately after the exertion
Other outcomes:
Locations:
city: Athens
country: Greece
facility: SismanoglioGH
city: Athens
country: Greece
facility: SismanoglioGH
Study officials:
References: