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OpenTrials
Completed

NCT Number: NCT03453138

Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

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 .

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Key information

Conditions

Laryngeal Mask Airway

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Ventilatory efficiency pressures for the LMA Protector

    Time frame: Intraoperative

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

Secondary outcomes

  1. Feasibility of LMA Protector

    Time frame: Intraoperative

    The grading of fiberoptic view of larynx through the LMA Protector

  2. Ease of insertion of LMA Protector

    Time frame: Intraoperative

    Each attemption to insert LMA will be record.

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: LMAP-LS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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