Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery (LMAP-LS)

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

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 .

Study Overview

• Status: Completed
• Conditions: Laryngeal Mask Airway
• Intervention / Treatment: Device: LMA Protector; Device: Tracheal Intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41900
    • Derince Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LMA Protector Group; 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; 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
EXPERIMENTAL: Tracheal Intubation Group; Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate	Device: Tracheal Intubation; tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed

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

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Principal Investigator: Mehmet Yılmaz, MD, Derince Research and Training Hospital

Publications and helpful links

General Publications

• Singh K, Gurha P. Comparative evaluation of Ambu AuraGain with ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017 Jun;61(6):469-474. doi: 10.4103/ija.IJA_163_17.
• Park SY, Rim JC, Kim H, Lee JH, Chung CJ. Comparison of i-gel(R) and LMA Supreme(R) during laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Oct;68(5):455-61. doi: 10.4097/kjae.2015.68.5.455. Epub 2015 Sep 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2017
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: laparoscopic surgery; laryngel mask airway
• Other Study ID Numbers: DerinceTRH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the reason is not to cause bias between the researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No