A research to evaluate and compare two medical devices(Proseal laryngeal mask airway and Gnana laryngeal airway II) use to ventilate the patients undergoing elective surgery under general anesthesia.

Phase 4

Not yet recruiting

• Conditions: All participants will either be ASA(American Society of Anaesthesiologists)grade 1 or 2

• Registration Number: CTRI/2019/04/018839
• Lead Sponsor: Government Medical college Hospital Sector Chandigarh

Brief Summary

This study is prospective,randomized,parallel group,active control trial where two devices Gnana LA II and Proseal laryngeal mask airway will be used for maintainence of airway during general anesthesia.These devices will be compared primarily in terms of oropharyngeal leak pressure(OLP),which signifies the efficacy of seal offered around laryngeal outlet.Secondary outcome measures will compare the overall efficacy of Gnana LA II and Proseal laryngeal mask airway by comparing the ease of insertion,fiberoptic visualization,hemodynamic and ventilatory parameters in paralysed patients undergoing elective surgery with controlled ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2019-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age group between 18 to 60 years 2.
• American Society of Anaesthesiologist (ASA) physical status I and II.
• Patients scheduled for elective surgery under general anaesthesia (Duration of surgery 2 ± 0.5 hrs).

Exclusion Criteria

• Patients with anticipated difficult airway (Airway Difficulty Score>8).22 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
1.To compare the oropharyngeak leak pressure ofProSeal laryngeal mask airway with Gnana laryngeal airway II in paralysed patients undergoing elective surgery with controlled ventilation .	immediately after the placement of device.

Secondary Outcome Measures

Name	Time	Method
2.To evaluate the efficacy of ProSeal laryngeal mask airway with Gnana laryngeal airway II for	device insertion success,

Trial Locations

Locations (1)

operation theatre; 🇮🇳 Chandigarh, CHANDIGARH, India

operation theatre

🇮🇳Chandigarh, CHANDIGARH, India

Mohit Garg

Principal investigator

7888446085

gargsmohit003@gmail.com