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

Primary Purpose

Respiratory Aspiration of Gastric Content

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-gel LMA insertion
AuraGain LMA insertion
ETT insertion
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Aspiration of Gastric Content focused on measuring Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    I-gel LMA

    AuraGain LMA

    Endotracheal tube (ETT)

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 5, 2016
    Last Updated
    May 6, 2017
    Sponsor
    Adiyaman University Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02925598
    Brief Title
    AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy
    Acronym
    AILMALC
    Official Title
    AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Adiyaman University Research Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Aspiration of Gastric Content
    Keywords
    Laringeal masks, Cholecystectomy, Laparascopic, Intubation, intratracheal

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I-gel LMA
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    AuraGain LMA
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Endotracheal tube (ETT)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    I-gel LMA insertion
    Intervention Description
    'I-gel LMA insertion' was done following anesthesia induction.
    Intervention Type
    Device
    Intervention Name(s)
    AuraGain LMA insertion
    Intervention Description
    'AuraGain LMA insertion' was done following anesthesia induction.
    Intervention Type
    Device
    Intervention Name(s)
    ETT insertion
    Intervention Description
    'ETT insertion' was done following anesthesia induction.
    Primary Outcome Measure Information:
    Title
    Insertion time
    Description
    It was assessed that how many secs it takes to insert the device
    Time Frame
    Perioperative
    Title
    Attempts to insertion
    Description
    It was assessed that how many attempts needed to insert the device
    Time Frame
    Perioperative
    Title
    Airway related complications
    Description
    Airway related complications like bronchospasm,gastric regurgitation,smooth tissue damages were assessed
    Time Frame
    Perioperative
    Secondary Outcome Measure Information:
    Title
    Heart Rate bpm
    Description
    Heart rates changes were evaluated preoperative and after device insertion and then in every 5 mins.
    Time Frame
    Perioperative
    Title
    Systolic blood pressure mmHg
    Description
    Systolic blood pressure changes were evaluate preoperative,following device insertion then in every 5 mins.
    Time Frame
    Perioperative
    Title
    Diastolic blood pressure mmHg
    Description
    Diastolic blood pressures were evaluated preoperative,following device insertion then in every 5 mins.
    Time Frame
    Perioperative
    Title
    Peak airway pressure
    Description
    During the surgery peak airway pressures were assessed following device insertion snd then in every 5 mins.
    Time Frame
    Perioperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulku Sabuncu, MD
    Organizational Affiliation
    Adiyaman university Research and Educational Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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