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Clinical Trials/CTRI/2025/01/079725
CTRI/2025/01/079725
Not yet recruiting
Phase 2

Comparison of Oropharyngeal Leak Pressure using i-Gel in Blind Technique Versuss Video Laryngoscope in Paediatric Patients undergoing Laparoscopic Surgeries: A Randomised Control Study

Armed Forces Medical College1 site in 1 country40 target enrollmentStarted: February 10, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
To compare oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope assisted placement.

Overview

Brief Summary

  1. The second-generation supraglottic airway (SGA) devices have revolutionized airway management in patients scheduled for surgery under general anaesthesia (GA). Each device possesses some unique features and has been used extensively in paediatric patients with varying degrees of success**.** The blind insertion technique is routinely used to insert the second generation supraglottic devices. Radiological studies have shown that incidence of malposition after blind insertion of LMA may range up to 50-80%. A study in paediatric patients undergoing magnetic resonance imaging found that radiologically proven malposition of LMA-unique was seen in 42.9% of children, though the clinical performance of LMA-unique was not hampered**.**

The advancement in anaesthesia practice is towards performing procedures under the vision and includes ultrasound assistance for regional blocks, ultrasound-guided central venous cannulation, fiberoptic/VL guided endotracheal intubation etc. Anaesthesiologists almost confirm the correct position of the ETT and corrective measures are immediately taken in the context of misplaced ETT but often accept sub optimally placed SGAs .

The Difficult Airway Society and the ASA difficult airway guidelines recommend blind airway management unreliable and Video laryngoscopy (VL) has become an integral part of airway management**.** VL offers better glottis visualization on the screen and enables correct placement of SGA beneath the glottis, thereby preventing epiglottic down folding or distal cuff displacement and improving functional or anatomical optimization of SGA .

Oropharyngeal leak pressure (OLP) refers to the airway leak or pressure airway sealing, and it is the most significant index for evaluating the security and effectiveness of airway tools**.** To quantify the effectiveness of airway sealing and protecting airway in tools, oropharyngeal leak pressure (OLP) is adopted . Under vision placement of SGA has reported a higher OPLP compared to blind insertion in adults**.**

Therefore, we planned a study to compare the video laryngoscope guided i-Gel insertion with that of the blind insertion technique in paediatric patients undergoing laparoscopic surgeries with regard to oropharyngeal leak pressure. We hypothesized that there would be no difference in the oropharyngeal leak pressure between the video laryngoscope guided and blind insertion technique of i-Gel in paediatric patients. The primary objective of the study was to compare the oropharyngeal leak pressure between blind and video laryngoscope guided insertion. Simultaneously, the insertion characteristics such as the number of attempts and the time required for successful insertion and the OPLP before and after pneumoperitoneum were also compared between two insertion techniques of IGEL in paediatric population.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Pediatric patients within a defined age range, typically from 1 year to 10 years old.
  • ASA I and II.

Exclusion Criteria

  • Suspected difficult airway.
  • Previous abdominal surgeries.
  • Any comorbidities that would affect time under anesthesia, intragastric pressure and abdominal pressure.
  • Weight of less than 5 kg.

Outcomes

Primary Outcomes

To compare oropharyngeal leak pressure using i-Gel in blind technique vs video laryngoscope assisted placement.

Time Frame: 03 Minutes after i-Gel placement

Secondary Outcomes

  • 1. Peak pressure before and(after pneumoperitoneum)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

SRIRAM

Armed Forces Medical College

Study Sites (1)

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