A research to evaluate and compare two medical devices (Ambu Aura Gain and Proseal Laryngeal Mask airway), used to ventilate patients undergoing general surgery.

Comparative evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway, in patients undergoing elective surgery under general anaesthesia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/07/005965

Enrollment

Registered

2015-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: AmbuAura Gain(AAG): Will be used to maintain the patency of airway during general anaesthesia. Will be inserted only once after induction of anaesthesia. Control Intervention1: Proseal

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Age group b/w 20 to 60 years 2. American Society of Anaesthesiologist (ASA) physical status I and II, and 3. Patients scheduled for elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: The following patients will be excluded from the study. 1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III/IV 2. Patients with mouth opening of less than 2.5 cm. 3. Patients with upper respiratory tract infection. 4. Patients with increased risk of regurgitation and aspiration (emergency surgeries and non-fasting patients). 5. Patients with a body mass index (BMI) > 35 kg.m.-2 6. Patients with past history of radiotherapy to the neck involving the hypopharynx. 7. Patients with expected duration of surgery of more than 2 hours.

Design outcomes

Primary

Measure	Time frame
To compare the oropharyngeal leak pressure (OLP) of Ambu AuraGain laryngeal mask and Proseal laryngeal mask airwayin patients undergoing elective surgery under general anaesthesia.Timepoint: immediately after the placement of the device.	—

Secondary

Measure	Time frame
To compare the overall efficacy of Ambu AuraGain and Proseal laryngeal mask airway by comparing the ease of insertion of device, ease of gastric tube placement, fibreoptic visualization, hemodynamic and ventilatory parameters, in patients undergoing elective surgery under general anaesthesia.Timepoint: 1. Ease of insertion of device, ease of gastric tube placement and fibreoptic visualization - will be observed immediately after the placement of device. 2. Hemodynamic and ventilatory parameters - every minute till 15 minutes after the placement of device.	—

Measure

Time frame

To compare the overall efficacy of Ambu AuraGain and Proseal laryngeal mask airway by comparing the ease of insertion of device, ease of gastric tube placement, fibreoptic visualization, hemodynamic and ventilatory parameters, in patients undergoing elective surgery under general anaesthesia.Timepoint: 1. Ease of insertion of device, ease of gastric tube placement and fibreoptic visualization - will be observed immediately after the placement of device. 2. Hemodynamic and ventilatory parameters - every minute till 15 minutes after the placement of device.

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Countries

India

Contacts

Public ContactRibhu Jindal

Government Medical college and hospital Sector 32

lkanand11@gmail.com9646121522

Outcome results