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Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway

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ClinicalTrials.gov Identifier: NCT03139292
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Deb Sanjay Nag, Tata Main Hospital

Brief Summary:
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.

Condition or disease Intervention/treatment Phase
Laryngeal Masks Device: ProSeal Laryngeal Mask Airway Device: AmbuAuraGain Laryngeal Mask Airway Not Applicable

Detailed Description:

The study aims to compare the two devices with respect to:

Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized single blinded parallel group controlled study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded
Primary Purpose: Device Feasibility
Official Title: Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia
Actual Study Start Date : May 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: ProSeal Laryngeal Mask Airway
Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion
Device: ProSeal Laryngeal Mask Airway
ProSeal Laryngeal Mask Airway was used as the supraglottic device

Experimental: AmbuAuraGain Laryngeal Mask Airway
Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion
Device: AmbuAuraGain Laryngeal Mask Airway
AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device




Primary Outcome Measures :
  1. Success rate for the first attempt at insertion [ Time Frame: 5 minutes ]
    A failed insertion attempt is defined as when removal of the device needed from the mouth.


Secondary Outcome Measures :
  1. Time taken for insertion [ Time Frame: 5 minutes ]
    Time taken for insertion from picking up the LMA till confirmation of effective ventilation

  2. The number of insertion attempts [ Time Frame: 5 minutes ]
    The number of insertion attempts or failed attempt to achieve effective ventilation. A failed insertion attempt is defined as when removal of the device needed from the mouth. Three attempts allowed before insertion will be considered a failure.

  3. Intracuff and the oropharyngeal leak pressures after ensuring effective placement. [ Time Frame: 5 minutes ]
    Intracuff and the oropharyngeal leak pressures after ensuring effective placement. These pressures will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min, note the airway pressure (maximum allowed: 40 cm H2O) at which equilibrium was reached.

  4. The time taken for orogastric tube placement [ Time Frame: 5 minutes ]
    The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Physical Status I & II
  2. Patients undergoing limb or breast surgery
  3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
  4. Patients with expected duration of surgery of less than 2 hours.

Exclusion Criteria:

  1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
  2. Patients with mouth opening of less than 2.5 cm or cervical spine disease
  3. Patients with H/o upper respiratory tract infection in the previous 10 days.
  4. Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
  5. Patients with a body mass index (BMI) > 30 kg/m2
  6. Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.

8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139292


Contacts
Contact: Deb Sanjay Nag, MD 6572319221 debsanjay@gmail.com

Locations
India
Tata Main Hospital Recruiting
Jamshedpur, Jharkhand, India, 831001
Contact: Deb Sanjay Nag    6572303411    debsanjay@gmail.com   
Sponsors and Collaborators
Tata Main Hospital

Responsible Party: Dr.Deb Sanjay Nag, Consultant, Tata Main Hospital
ClinicalTrials.gov Identifier: NCT03139292     History of Changes
Other Study ID Numbers: 201-26104-152-206580
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No