To compare two methods of removal of a tube at the end of anaesthesia using a device called I-gel

Not yet recruiting

• Conditions: Other specified symptoms and signsinvolving the circulatory and respiratory systems,

• Registration Number: CTRI/2024/01/061401
• Lead Sponsor: AIIMS Mangalariri

Brief Summary

Extubation marks the period of transition froman established airway to a normal natural airway. Similar to intubation,extubation is associated with numerous complications such as bronchospasm,laryngospasm, airway obstruction etc. These can lead to extubation failure andreintubation. Extubation is also associated with haemodynamic stress responsewhich cannot be tolerated in patients with underlying cardiovascular disease, orin patients undergoing intracranial or intraocular surgeries.  All of these increase morbidity andmortality. NAP4 reported a mortality of 5% in patients with extubation failureafter general anaesthesia. The Difficult Airway Society (DAS) guidelines andalso the recent All India Difficult Airway Guidelines (AIDAA) mention the useof supraglottic airway devices (SGAD) as a rescue device in the event of a failedintubation and also as a bridge to extubate patients in whom the haemodynamicstress response needs to be attenuated. Asai and later Raveendran et al described two techniques of extubation over a SGAD. The SGAD devices used in these techniques are classic LMA and Proseal LMA respectively. We plan to use I-gel, a novel device that has been time-tested.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Patients belonging to the age group 18 to 65 years 2.ASA PS I – III 3.Intubation difficulty score (IDS) ≤ 5 4.Scheduled for surgery under general anaesthesia.

Exclusion Criteria

2.IDS > 5 3.Predictors of difficult LMA insertion 4.Patients who are at risk of aspiration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to compare the success rate of placement of I-gel (SGAD) using the Airway Exchange Catheter (AEC) technique with Asai’s technique in patients with an unanticipated difficult airway.	At 1 min after the successful insertion of I-gel using either of the 2 techniques, FOB will be performed to grade the view of the laryngeal inlet

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes which will be evaluated are the haemodynamic changes, the time & number of attempts taken to insert the I-gel, 1st attempt success rate, the grade of laryngeal view attained using a fibreoptic bronchoscope, the incidence of other airway-related complications like sore throat, trauma, laryngospasm & bronchospasm in the perioperative period.	Haemodynamics will be monitored at 1 min, 5min & 10min after insertion of the I gel

Trial Locations

Locations (1)

AIIMS Mangalagiri; 🇮🇳 Guntur, ANDHRA PRADESH, India

AIIMS Mangalagiri

🇮🇳Guntur, ANDHRA PRADESH, India

Dr Eeshwar M V

Principal investigator

9740122272

dreeshwarmv@aiimsmangalagiri.edu.in