COMPARATIVE STUDY BETWEEN I-GEL AND LMA-CLASSIC IN ANAESTHETISED, SPONTANEOUSLY BREATHING ADULT PATIENTS UNDERGOING ELECTIVE SURGICAL PROCEDURES

Not yet recruiting

• Conditions: American Society of Anaesthesiologists (ASA) grade I-II

• Registration Number: CTRI/2018/06/014506
• Lead Sponsor: KPC MEDICAL COLLEGE AND HOSPITAL

Brief Summary

Maintenance of airway with minimal complications is utmost priority of anaesthesiologist during anaesthesia to provide adequate ventilation to the patient. Endotracheal intubation is the gold standard method for this purpose, but some undesirable complications are associated with it e.g, haemodynamic instability as it requires laryngoscopy.

Laryngeal Mask Airway(LMA) has revolutionized airway management and is an excellent alternative to mask ventilation and tracheal intubation during General Anaesthesia (GA).

I-gel has been designed to improve efficacy in terms of airway-seal and safety in terms of protection from gastric aspiration which is not seen in Classic LMA (CLMA). They are easily inserted, better-tolerated with lesser haemodynamic changes, have favorable respiratory mechanics and decreased airway morbidity with minimal risk of tissue compression. As the elimination of cuff inflation shorten insertion-time, it is advantageous to be used during Cardio Pulmonary Resuscitation (CPR) by non-anaesthetists and in emergency situations requiring prompt airway care in which time is very-important.

Therefore,this prospective, randomised,comparative study will be carried out in 100 anaesthetised spontaneously breathing adult patients of both genders, aged between (15-60) years with American Society of Anesthesiologists (ASA) physical status I or, II and Mallampatti grade I or II, posted for elective surgeries under General Anaesthesia (GA) using either the I-gel or, Classic LMA (CLMA) at operation theatres in KPC MEDICAL COLLEGE AND HOSPITAL for 2 years. We will compare the safety and efficacy of I-gel and CLMA regarding the device-insertion parameters (like, insertion time, number of insertion attempts and ease of insertion), perioperative haemodynamic parameters like Heart Rate, Non invasive Blood Pressure, Oxygen saturation (SPO2) and End tidal CO2 (EtCO2) due to device insertion. Appropriate statistical methods will be applied.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-11-06
• Study Start: 2018-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• INCLUSION CRITERIA The surgical procedures taken into consideration are 1)Adult patients of either sex aged between (15-60) years.
• 2)American Society of Anaesthesiologists (ASA) grade I-II 3)Mallampatti (MP) grade I and II 4)Body Mass Index (BMI) between (20-25) kg/m² 5)Scheduled for elective surgeries under general anaesthesia, not requiring muscle relaxation.

Exclusion Criteria

• EXCLUSION CRITERIA The following patients will be excluded from the study 1)Age < 15 years and > 60 years.
• 2)American Society of Anaesthesiologists (ASA) grade III and IV 3)Mallampatti (MP) grade 3 and 4 4)Patients having any abnormality of the neck, anticipated difficult airway.
• 5)Mouth opening < 2 cm.
• 6)Upper respiratory tract infection.
• 7)History of Obstructive Sleep Apnoea.
• 8)Obese patients with Body Mass Index (BMI) > 28 kg/m² 9) Patients with increased risk of aspiration.
• 10. Duration of surgery > 1 hour.
• 11. Pregnant females.
• 12. Patients with reported history of hypersensitivity for one or more medications and latex.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2)Number of insertion attempts.	2 years
PRIMARY OBJECTIVES	2 years
To study and compare two supraglottic airway devices, I-gel and Classical laryngeal mask airway, in anaesthetized adult patients with spontaneous ventilation during elective surgical procedures, with respect to	2 years
1)Time taken for insertion.	2 years
3)Ease of insertion, any manipulations required.	2 years

Trial Locations

Locations (1)

KPC MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Kolkata, WEST BENGAL, India

KPC MEDICAL COLLEGE AND HOSPITAL

🇮🇳Kolkata, WEST BENGAL, India

ANUPAMA MONDAL

Principal investigator

8640919687

mondal.anupama8@gmail.com