Evaluation of a medical device used in anaesthesia for securing airway- AMBU AuraGainâ?¢
Phase 4
- Conditions
- Health Condition 1: null- Patients undergoing elective surgery and requiring general anaesthesia
- Registration Number
- CTRI/2016/10/007366
- Lead Sponsor
- okmanya Tilak Municipal Medical College And General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
All patients in whom AMBU AuraGain is inserted
ASA I/II
Exclusion Criteria
1.History of gastroesophageal reflux
2.Abnormal airway anatomy or anticipated difficult intubation
3.BMI > 30kg/m2
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Ease of placement of device <br/ ><br>2.To determine the position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope, <br/ ><br>3.To test its efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes in paralyzed adult patients <br/ ><br>Timepoint: Ease of placement of device- will be seen during insertion of device <br/ ><br>Position of the ventilating orifice in relation to the larynx using a fibreoptic bronchoscope -will be assesed after insertion of device <br/ ><br>Efficacy as a conduit for fibreoptic intubation with cuffed tracheal tubes- will be assesed during intubation through the device <br/ ><br>
- Secondary Outcome Measures
Name Time Method Ability to remove the ILA without dislodgement of the tracheal tube <br/ ><br>Timepoint: Immediately after successful tracheal intubation. <br/ ><br>;Hemodynamic changes after insertion of deviceTimepoint: 1 minute, 3 minutes and 5 minutes after insertion of AMBU AuraGain