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

ConditionsAirway ManagementGeneral Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNikolopoulou Maria Zozefin

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA I-II

Patients older than 18 years

Procedures in supine and lithotomy position

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LMA igel

    Device

    adults allocated to the LMA igel group, an LMA igel device will be inserted intraoperatively

  • LMA protector

    Device

    adults allocated to the LMA protector group, an LMA protector device will be inserted intraoperatively

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: LMA igel groupActive comparator 1 intervention
Group B: LMA protector groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions

After the closure of the adjustable pressure limiting valve (APL) of the ventilation machine with a continuous fresh gas flow of 3L/min, a stethoscope for auscultation will be placed to the lateral position of the thyroid cartilage. Leak pressure is defined as the maximum airway pressure (Ppeak) during which no audible sound, like leak, is detected with the placement of the stethoscope at the thyroid cartilage. Successful placement of the laryngeal mask, will be confirmed right after insertion by the auscultation of both hemithoraces, the indication of capnography, and the ratio of inhaled to exhaled pulmonary volume

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 outcomes

1

Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index

The Simplified Airway Risk Index is a multivariate risk score, ranging from 0 to 12 points, thought to estimate the risk of difficult tracheal intubation based on seven parameters. These seven parameters include the mouth opening, where a mouth opening greater than 4 centimeters between the incisors results in 0 points whereas a distance below results in 1 point, the thyromental distance where thyromental distance greater than 6.5 centimeters results in 0 point whereas a distance between 6-6.5 centimeters is given 1 point and finally a distance below 6 centimeters is given 2 points, the mallampati score where Class I and II of the modified mallampati scoring results in 0 points whereas a class III is given 1 point and a class IV 2 points, the movement of the neck where the ability to move the neck more than 90 degrees results in 0 points whereas a movement range of 80-90 degrees results in 1 point and a movement range below 80 degrees results in 2 points, the ability to underbite mean

Time frame
The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation
2

The time required for successful placement of the device

This process will involve a maximum of three attempts

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
3

Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask

The ease of placement will be assessed by counting the number of attempts required to successfully place the nasogastric tube. Success is defined as the ability to place the tube without complications. "Easy" is defined as successful placement on the first attempt, "moderate" as placement on the second attempt, and "difficult" as placement on the third attempt. If placement is not achieved within three attempts, the procedure will be considered unsuccessful. Successful placement will by assessed by the successful suction of gastric fluid

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
4

Documentation of adverse events after the exertion

Complications like blood-stain visible on the LMA after exertion and post-operative sore throat

Time frame
Immediately after the exertion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nikolopoulou Maria Zozefin

Lead sponsor

Sismanoglio General Hospital

Sponsor institution

Source ClinicalTrials.gov
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