Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .

Detailed Description
-----------------
Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.

Official Title
-----------------
The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial

Conditions
-----------------
Laryngeal Mask Airway

Intervention / Treatment
-----------------
* Device: LMA Protector
* Device: Tracheal Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-III patients Patients undergo laparoscopic surgeries Laparoscopic surgeries duration of less than 2 hours Exclusion Criteria: Difficult intubation history BMI>35 Open cholesistectomies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA Protector Group<br>LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale | Device: LMA Protector<br>* LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale<br>|
| Experimental: Tracheal Intubation Group<br>Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate | Device: Tracheal Intubation<br>* tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilatory efficiency pressures for the LMA Protector | Oropharyngeal pressure leak test, the peak airway pressures will be determined | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of LMA Protector | The grading of fiberoptic view of larynx through the LMA Protector | Intraoperative | 
| Ease of insertion of LMA Protector | Each attemption to insert LMA will be record. | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngel mask airway, laparoscopic surgery