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Recruiting NCT06825910

LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

No phase Interventional Airway Management General Anesthesia

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, General Anesthesia. 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

Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study

Overview

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.

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

  • Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions [Time frame: 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 outcome measures (4)
  • Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index [Time frame: The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation]
  • 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]
  • Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask [Time frame: 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]
  • Documentation of adverse events after the exertion [Time frame: Immediately after the exertion]

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
Single blind
Primary purpose
Other

Study locations

Greece · 2 centers
  • SismanoglioGH — Athens
  • SismanoglioGH — Athens

Identifiers

NCT: NCT06825910 · 19242/29.08.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗