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

Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03453138
Collaborator
(none)
154
Enrollment
1
Location
2
Arms
4.1
Actual Duration (Months)
37.2
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Device: LMA Protector
  • Device: Tracheal Intubation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial
Actual Study Start Date :
Dec 26, 2017
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ventilatory efficiency pressures for the LMA Protector [Intraoperative]

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

Secondary Outcome Measures

  1. Feasibility of LMA Protector [Intraoperative]

    The grading of fiberoptic view of larynx through the LMA Protector

  2. Ease of insertion of LMA Protector [Intraoperative]

    Each attemption to insert LMA will be record.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Derince Research and Training Hospital Kocaeli Turkey 41900

Sponsors and Collaborators

  • Derince Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ayse Zeynep Turan, Principal Investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03453138
Other Study ID Numbers:
  • DerinceTRH-01
First Posted:
Mar 5, 2018
Last Update Posted:
May 9, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Ayse Zeynep Turan, Principal Investigator, Derince Training and Research Hospital
laryngel mask airway
laparoscopic surgery

Study Results

No Results Posted as of May 9, 2018