Assessment of new airway device [Gnana Laryngeal Airway]: a preliminary clinical study.
- Conditions
- American Society of Anesthesiologists (ASA) I/II patients scheduled for elective surgeries requiring general anaesthesia.
- Registration Number
- CTRI/2017/12/010782
- Lead Sponsor
- Director Principal
- Brief Summary
Laryngeal mask airway (LMA) devices are presently use worldwide by anaesthesiologist for airway management in adults and children’s and is considered a novel route to provide general anaesthesia. There are currently seven versions of the LMA’s available, which are LMA-Classic, LMA-Unique, LMA-Fastrach, LMA-ProSeal, LMA-Supreme, LMA-Ambu and LMA-Soft Seal. Recently, a laryngeal airway device was designed as a latest version of LMA called Gnana laryngeal airway. It consists of an elliptical cuffed mask and an airway tube. The concave portion of the mask when inflated faces the vocal cords. With the aim of keeping the area around the laryngeal mask clean of secretions, an inbuilt small suction port has been added into convex part of the laryngeal mask airway. there are numerous clinical studies involving the use of various version of LMAs, attesting to their safety and performance in various clinical situations. It is hypothesised that the Gnana laryngeal airway might reduce the possible airway complication by incorporation of suction port on its convex surface. At present there are limited trials done on the Gnana laryngeal airway. The purpose of this study is to evaluate Gnana laryngeal airway in terms of success rate, ease and speed of insertion, performance during general anaesthesia (oropharyngeal leak pressure (OLP) measurement after insertion of device by documented method and exact placement of device seen by flexible fiberoptic view of larynx) and rate of complications in patients requiring anaesthesia for various surgical procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
1.American Society of Anesthesiologist (ASA) physical status 1 and 2 of either sex 2.Age group: 18-60 years 3.Body Mass Index (BMI): <30 kg/ m2 4.Scheduled for elective surgeries with duration <2 hours and requiring general anaesthesia with controlled ventilation 5.No concurrent participation in another study.
1.Patients’ refusal or inability to give informed consent 2.American Society of Anesthesiologist (ASA) ≥3 physical status of either sex 3.Emergency surgical procedures 4.Upper respiratory tract infection 5.Anticipated difficult airway 6.Patients at increased risk of aspiration -gastro esophageal reflux disease, non fasting status, pregnancy 7.Cardiorespiratory or cerebrovascular disease 8.Diabetes Mellitus.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ease of insertion grade of Gnana laryngeal airway device. Immediately Post-induction of general anaesthesia. [Single time point]
- Secondary Outcome Measures
Name Time Method 1.Time taken for Gnana laryngeal airway device insertion. 2. Oropharyngeal Leak Pressure of Gnana airway device.
Trial Locations
- Locations (1)
Govt. Medical College and Hospital, Sector 32, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Govt. Medical College and Hospital, Sector 32, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDHEERAJ KAPOORPrincipal investigator9646121549kapoor.dheeraj72@gmail.com