Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Laryngeal Mask Airway
• Interventions: Device: LMA Protector; Device: Tracheal Intubation

• Registration Number: NCT03453138
• Lead Sponsor: Derince Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-12-26
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-05
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Protector Group	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
Tracheal Intubation Group	Tracheal Intubation	Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate

Primary Outcome Measures

Name	Time	Method
Ventilatory efficiency pressures for the LMA Protector	Intraoperative	Oropharyngeal pressure leak test, the peak airway pressures will be determined

Secondary Outcome Measures

Name	Time	Method
Feasibility of LMA Protector	Intraoperative	The grading of fiberoptic view of larynx through the LMA Protector
Ease of insertion of LMA Protector	Intraoperative	Each attemption to insert LMA will be record.

Trial Locations

Locations (1)

Derince Research and Training Hospital; 🇹🇷 Kocaeli, Turkey