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Clinical Trials/CTRI/2025/06/089121
CTRI/2025/06/089121Not yet recruitingNot Applicable

Comparative study of two techniques of I-GEL Insertion modified Jaw Thrust and ReverseTechnique of I-GEL Insertion by new Trainees in patient undergoing General Anaesthesia – A RandomizedClinical Trial

Shree Krishna hospital1 site in 1 country78 target enrollmentStarted: January 7, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
78
Locations
1
Primary Endpoint
To compare time taken for I-GEL insertion on 1st attempt by Modified jaw thrust and Reverse technique by new trainees

Study Overview

Brief Summary

Supraglottic airway devices (SADs), like the I-gel, are increasingly utilized in anesthesia and emergency care due to their ease of insertion and reduced invasiveness compared to tracheal intubation. The I-gel, a second-generation SAD with a thermoelastic cuff, is designed to conform to the patient’s anatomy, minimizing trauma during insertion. However, standard insertion techniques can sometimes be hindered by anatomical challenges, such as tongue folding or resistance in the oropharynx.

To address these challenges, several alternative insertion techniques have been developed:

  • Modified Jaw Thrust Technique: This method involves the operator using their little fingers to lift the mandible while stabilizing the jaw with the other fingers, allowing the thumbs to advance the I-gel into position. This technique has demonstrated a 100% first-attempt success rate in a case series, with an average insertion time of approximately 11 seconds and minimal trauma.
  • Reverse Insertion Technique: In this approach, the I-gel is inserted with its concavity facing the hard palate. Upon reaching the oropharynx, it is rotated 180° into its final position. This method has been effective in cases where the standard technique failed due to tongue folding.
  • Rotational Technique: This technique involves rotating the I-gel 90° during insertion to reduce tongue folding and facilitate smoother placement. Studies have shown higher first-attempt success rates with this method compared to the standard technique.

These alternative techniques can be particularly beneficial for trainees or in scenarios where standard insertion proves challenging. Implementing these methods may improve insertion success rates and reduce complications associated with airway management.

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Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient willing to sign the written informed consent.
  • Belonging to ASA grade 1, 2 ,
  • Male or female between the age range of 18-80 years.
  • Surgery in supine position.
  • Patient undergoing elective surgeries for duration more than 15min to less than 8 hours under general anaesthesia.
  • Procedure will be performed by new trainees.

Exclusion Criteria

  • •Patients unwilling to participate.
  • •Patients belonging to ASA grade 4 or more.
  • •Pregnant and lactating women.
  • •Age below 18 years.
  • •Known case of Esophageal disease (cancer, varices) •Patient with gastroesophageal reflex disease, abnormal head and neck, airway abnormality.
  • •Limited mouth opening (less than 2 finger).
  • •Local pathology in pharynx, larynx or upper airway .
  • •Surgery in prone position.
  • •Morbidly obese (BMI 40 or more).

Outcomes

Primary Outcomes

To compare time taken for I-GEL insertion on 1st attempt by Modified jaw thrust and Reverse technique by new trainees

Time Frame: To compare time taken for I-GEL insertion on 1st attempt by Modified jaw thrust and Reverse technique by new trainees,Time taken from I-gel insertion to first ventilation is less than 60 seconds, 60 to 120 seconds,more than 120 seconds

Secondary Outcomes

  • To compare the Post operative sore throat between two techniques within 1 hour of I-gel removal
  • Secondary Objectives: 1) To compare the success rate between the two techniques.

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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