A research to evaluate and compare two medical devices ( Air Q-SP and Proseal laryngeal mask airway) use to ventilate the patients undergoing elective surgery under general anaesthesia.
Phase 4
Completed
- Registration Number
- CTRI/2018/02/011737
- Lead Sponsor
- Government Medical College and Hospital Sector Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 95
Inclusion Criteria
Inclusion criteria
1.Age group between 18 to 60 years
2.American Society of Anaesthesiologist (ASA) physical status I and II.
3.Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ± 0.5 hrs)
Exclusion Criteria
The following patients will be excluded from the study.
1.Patients with anticipated difficult airway (Airway Difficulty Score >8).
2.Patients with upper respiratory tract infection
3.Patients with increased risk of regurgitation and aspiration of gastric content
4.Patients with a body mass index (BMI) > 35 kg.m.-2
5.Patients with past history of radiotherapy to the neck involving the hypopharynx
6.Patients undergoing surgeries involving neck and oral cavity
7.Pregnant patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the oropharyngeal leak pressure of Air-Q SP and Proseal Laryngeal Mask Airway in patients undergoing elective surgery under general anaesthesia.Timepoint: immediately after the placement of device
- Secondary Outcome Measures
Name Time Method To compare the overall efficacy of Air-Q SP and Proseal laryngeal mask airway by comparing the ease of insertion, fiberoptic visualization, hemodynamic and ventilatory parameters,in patients undergoing elective surgery under general anaesthesiaTimepoint: 1. Ease of insertion, fiberoptic visualization- will be observed immediately after placement of device. <br/ ><br>2. Hemodynamic and ventilatory parameters- at 1, 2, 3, 4, 5 and 10 minutes