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

NCT ID: NCT03139292

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Laryngeal Masks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized single blinded parallel group controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded

Study Groups

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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

Group Type EXPERIMENTAL

ProSeal Laryngeal Mask Airway

Intervention Type DEVICE

ProSeal Laryngeal Mask Airway was used as the supraglottic device

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

Group Type EXPERIMENTAL

AmbuAuraGain Laryngeal Mask Airway

Intervention Type DEVICE

AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Interventions

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ProSeal Laryngeal Mask Airway

ProSeal Laryngeal Mask Airway was used as the supraglottic device

Intervention Type DEVICE

AmbuAuraGain Laryngeal Mask Airway

AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tata Main Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Deb Sanjay Nag

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tata Main Hospital

Jamshedpur, Jharkhand, India

Site Status

Countries

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India

Other Identifiers

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201-26104-152-206580

Identifier Type: -

Identifier Source: org_study_id