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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Aspiration of Gastric Content
• Intervention / Treatment: Device: I-gel LMA insertion; Device: AuraGain LMA insertion; Device: ETT insertion

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-gel LMA; I-gel LMA insertion: I-gel insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform.	Device: I-gel LMA insertion; 'I-gel LMA insertion' was done following anesthesia induction.
Experimental: AuraGain LMA; AuraGain insertion:AuraGain LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform.	Device: AuraGain LMA insertion; 'AuraGain LMA insertion' was done following anesthesia induction.
Experimental: Endotracheal tube (ETT); Endotracheal tube insertion: Endotracheal tube (ETT) insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and EtCO2 waveform.	Device: ETT insertion; 'ETT insertion' was done following anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion time	It was assessed that how many secs it takes to insert the device	Perioperative
Attempts to insertion	It was assessed that how many attempts needed to insert the device	Perioperative
Airway related complications	Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate bpm	Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.	Perioperative
Systolic blood pressure mmHg	Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.	Perioperative
Diastolic blood pressure mmHg	Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.	Perioperative
Peak airway pressure	During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.	Perioperative

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital
• Investigators: Principal Investigator: Ulku Sabuncu, MD, Adiyaman university Research and Educational Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Intubation, intratracheal; Laringeal masks; Cholecystectomy, Laparascopic
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: 2015/178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO