Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

NCT ID: NCT03453138

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-26

Study Completion Date

2018-05-01

Brief Summary

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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

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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.

Conditions

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Laryngeal Mask Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

LMA Protector

Intervention Type DEVICE

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

Patients will be intubated after standart anesthesia induction and we will record heamodynamic variables. including mean blood pressure and heart rate

Group Type EXPERIMENTAL

Tracheal Intubation

Intervention Type DEVICE

tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ayse Zeynep Turan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Yılmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Derince Research and Training Hospital

Locations

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Derince Research and Training Hospital

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28655951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26495055 (View on PubMed)

Other Identifiers

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DerinceTRH-01

Identifier Type: -

Identifier Source: org_study_id

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