A research to evaluate and compare two medical devices (Blockbuster and Fastrach Laryngeal Mask Airway), used to ventilate patients undergoing surgery.
Phase 4
Completed
- Conditions
- Health Condition 1: null- All participants will be either ASA ( American Society of Anaesthesiologists) grade 1 or 2.
- Registration Number
- CTRI/2018/02/011947
- Lead Sponsor
- Government medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
The following patients would be included for the study
1. Age group of 18 to 60 years
2. American Society of Anesthesiologists (ASA) status I and II
3. Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation.
Exclusion Criteria
The following patients would be included for the study
1. Morbid obesity BMI > 35 kg/m2
2. Patients with anticipated difficult airway (Airway Difficulty Score >8)
3. Patients at increased risk of aspiration like gastroesophageal reflux, peptic ulcer
4. Previous upper gastrointestinal surgery
5. Coagulopathy or history of anticoagulant use 6. Cardiorespiratory or cerebrovascular disease 7. Cervical spine injury
8. Pregnant patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the success rate of tracheal intubation with BlockBuster and Fastrach Laryngeal Mask Airway.Timepoint: immediately after the placement of the device
- Secondary Outcome Measures
Name Time Method To compare insertion success rates of two Laryngeal Mask Airwayâ??s, oropharyngeal leak pressure, fiberoptic visualization of glottis, hemodynamic parameters and post-operative complication if any. <br/ ><br>Timepoint: 1. Ease of insertion of device, ease of use of gastric tube placement and fiberoptic visualization- will be observed immediately after the placement of the device. <br/ ><br>2. Hemodynamic and ventilatory parameters- every minute till 15 min after the placement of device.