Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

NCT03453138 | Completed

• 1 other identifier: DerinceTRH-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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 .

Conditions

Laryngeal Mask Airway

Keywords

laryngel mask airway; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Ventilatory efficiency pressures for the LMA Protector

  Oropharyngeal pressure leak test, the peak airway pressures will be determined

  Intraoperative

Secondary Outcomes (2)

• Feasibility of LMA Protector

  Intraoperative

• Ease of insertion of LMA Protector

  Intraoperative

Study Arms (2)

LMA Protector Group

EXPERIMENTAL

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

Tracheal Intubation Group

EXPERIMENTAL

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

Device: Tracheal Intubation

Interventions

LMA Protector 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

LMA Protector Group

Tracheal Intubation DEVICE

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

Tracheal Intubation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I-III patients
• Patients undergo laparoscopic surgeries
• Laparoscopic surgeries duration of less than 2 hours

You may not qualify if:

• Difficult intubation history
• BMI\>35
• Open cholesistectomies

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28655951 BACKGROUND

• 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.

  PMID: 26495055 BACKGROUND

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Mehmet Yılmaz, MD

  Derince Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: March 5, 2018
• Study Start: December 26, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)