Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery

Laryngeal Mask Airway Clinical Trial

— LMAP-LS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453138
• Other study ID #: DerinceTRH-01
• Status: Completed
• Phase: N/A
• Start date: December 26, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Mask Airway

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Derince Research and Training Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Park SY, Rim JC, Kim H, Lee JH, Chung CJ. Comparison of i-gel® and LMA Supreme® during laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Oct;68(5):455-61. doi: 10.4097/kjae.2015.68.5.455. Epub 2015 Sep 30. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory efficiency pressures for the LMA Protector	Oropharyngeal pressure leak test, the peak airway pressures will be determined	Intraoperative
Secondary	Feasibility of LMA Protector	The grading of fiberoptic view of larynx through the LMA Protector	Intraoperative
Secondary	Ease of insertion of LMA Protector	Each attemption to insert LMA will be record.	Intraoperative