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Clinical Trials/CTRI/2024/10/075505
CTRI/2024/10/075505
Not yet recruiting
Phase 4

Comparative efficacy of I-Gel, Laryngeal Mask Airway-Supreme and Laryngeal Mask Airway-Protector in Short Surgical Procedures under General Anaesthesia with Spontaneous Ventilation - A Randomised Clinical Trial

Dr Damandeep Kaur1 site in 1 country120 target enrollmentStarted: November 1, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Damandeep Kaur
Enrollment
120
Locations
1
Primary Endpoint
To compare the efficacy of I-Gel, LMA Supreme, and LMA Protector in maintaining a patent airway during short surgical procedures.

Overview

Brief Summary

While previous studies have compared different supraglottic airway devices or focused on other aspects, a dedicated investigation directly comparing these three commonly used devices could offer more precise guidance to clinicians in selecting the most suitable device for positive pressure ventilation in anesthetized patients. Therefore, our study aims to fill this gap by providing a comprehensive comparison among I-Gel, LMA-Supreme and LMA Protector, focusing on insertion ease, insertion time, placement attempts, airway leak pressure, and complications, ultimately aiming to optimize patient care and outcomes in anesthesia settings.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Grading I ,II Patients undergoing elective short surgeries less than 1.5hrs under general anaesthesia.

Exclusion Criteria

  • Non Consenting Patient BMI more than 30Kg/m2 Difficult airway MPC Class ≥3 Uncontrolled Co-morbid illness H/O GERD, Hiatus Hernia Musculo-skeletal Abnormalities Like Cervical Spine Deformities Obstructive Sleep Apnea.

Outcomes

Primary Outcomes

To compare the efficacy of I-Gel, LMA Supreme, and LMA Protector in maintaining a patent airway during short surgical procedures.

Time Frame: Baseline(To) | 1 min after insertion T1 | 3 min T2 | 5 min T3 | 15 min T4 | 30 min T5 | 45 min T6 | 60 min T7 | 75 min T8 | 90 min T9 | 105min T10

Secondary Outcomes

  • To evaluate the insertion characteristics, including ease and success rates, of the three supraglottic airway devices.

Investigators

Sponsor
Dr Damandeep Kaur
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Damandeep Kaur

Adesh Institute of Medical Sciences and Research

Study Sites (1)

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