AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy

Respiratory Aspiration of Gastric Content Clinical Trial

— AILMALC  

Official title:

AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925598
• Other study ID #: 2015/178
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: May 6, 2017
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: May 2017
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.

Description:

The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• (ASA) 1-2 physical status scheduled for elective LC

Exclusion Criteria:

• under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) > 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Aspiration of Gastric Content
• Respiratory Aspiration of Gastric Contents

Intervention

Device:
• I-gel LMA insertion
'I-gel LMA insertion' was done following anesthesia induction.
• AuraGain LMA insertion
'AuraGain LMA insertion' was done following anesthesia induction.
• ETT insertion
'ETT insertion' was done following anesthesia induction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion time	It was assessed that how many secs it takes to insert the device	Perioperative
Primary	Attempts to insertion	It was assessed that how many attempts needed to insert the device	Perioperative
Primary	Airway related complications	Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed	Perioperative
Secondary	Heart Rate bpm	Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.	Perioperative
Secondary	Systolic blood pressure mmHg	Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.	Perioperative
Secondary	Diastolic blood pressure mmHg	Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.	Perioperative
Secondary	Peak airway pressure	During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.	Perioperative