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

• Sponsor: Tata Main Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03139292
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized single blinded parallel group controlled studyProspective 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: Treatment
• 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 1, 2016
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Success rate for the first attempt at insertion [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 [5 minutes]

   Time taken for insertion from picking up the LMA till confirmation of effective ventilation

2. The number of insertion attempts [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. [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 [5 minutes]

   The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tata Main Hospital	Jamshedpur	Jharkhand	India	831001

Sponsors and Collaborators

• Tata Main Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr.Deb Sanjay Nag, Consultant, Tata Main Hospital
• ClinicalTrials.gov Identifier: NCT03139292
• Other Study ID Numbers: 201-26104-152-206580
• First Posted: May 3, 2017
• Last Update Posted: Dec 30, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 30, 2019