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

NCT03139292 | Completed

• 1 other identifier: 201-26104-152-206580
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• Success rate for the first attempt at insertion

  A failed insertion attempt is defined as when removal of the device needed from the mouth.

  5 minutes

Secondary Outcomes (4)

• Time taken for insertion

  5 minutes

• The number of insertion attempts

  5 minutes

• Intracuff and the oropharyngeal leak pressures after ensuring effective placement.

  5 minutes

• The time taken for orogastric tube placement

  5 minutes

Study Arms (2)

ProSeal Laryngeal Mask Airway

EXPERIMENTAL

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

AmbuAuraGain Laryngeal Mask Airway

EXPERIMENTAL

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

Interventions

ProSeal Laryngeal Mask Airway DEVICE

ProSeal Laryngeal Mask Airway was used as the supraglottic device

ProSeal Laryngeal Mask Airway

AmbuAuraGain Laryngeal Mask Airway DEVICE

AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

AmbuAuraGain Laryngeal Mask Airway

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Main Hospital: lead

Study Sites (1)

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Prospective randomized single blinded parallel group controlled study

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)