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Clinical Trials/CTRI/2022/10/046760
CTRI/2022/10/046760Not yet recruitingNot Applicable

A Comparative Study of Respiratory mechanics in Patients undergoing day care laparoscopic cholecystectomy using LMA ProSeal vs LMA Protector.

Sir Ganga Ram Hospital1 site in 1 country50 target enrollmentStarted: January 11, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Comparison of dynamic compliance using LMA® ProSeal™ vs. LMA® Protector™ in patients undergoing lap cholecystectomy.

Study Overview

Brief Summary

Minimally invasive laparoscopic surgery has revolutionized surgical practice and influenced the practice of anaesthesiology. Improvement in surgical and anaesthetic techniques has led to surgeries being performed on an outpatient basis with better pain management,early recovery and short duration of admission.General anaesthesia with controlled ventilation is the technique of choice in laparoscopic surgeries.

The record success of laryngeal mask airway in resuscitation, difficult airway management and anaesthesia lead to the introduction of several supraglottic airway devices (SADs) into clinicalpractice.SADsoffer several advantages over endotracheal tubes including ease of insertion, reduced haemodynamic response,decreased airway tolerance and lesser pharyngolaryngealmorbidity.1-5 The introduction of second-generation SADs having gastric drainage tube provide a better oropharyngeal seal and improved protection against regurgitation and pulmonary aspiration.

LMA®  Protectorâ„¢ is a recently developed SAD  with few published studies on its utility to date. It is made of medical-grade silicone which makes it more flexible and less traumatic than previous LMA devices made up of PVC. It is a single-use second generation SAD designed with a large volume conduit with gastric assess and a fixed curved structure to facilitate insertionand an inflatable airway cuff.6 Additionally, the LMA  Protector is available with a pilot balloon or the integrated cuff pilot that provides easier adjustment of the intracuff pressure.7

Since LMA®  Protectorâ„¢ was introduced in 2015 as the most advanced second-generation device, we want to compare this device with LMA® ProSealâ„¢, one of the most frequently used devices in any institution. Until now, only a few studies have compared the clinical efficacy of the LMA®  Protectorâ„¢ with other SADs.

In this study, we aim to compare the respiratory mechanics with LMA® ProSealâ„¢ *vs.*LMA®  Protectorâ„¢ in patients undergoing day care laparoscopic cholecystectomy.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA physical status 1 and 2 2.

Exclusion Criteria

  • Patient with upper respiratory tract infection
  • Patient at risk of aspiration
  • Anticipated difficult airway
  • Patient with lung disease patient refusal.

Outcomes

Primary Outcomes

Comparison of dynamic compliance using LMA® ProSeal™ vs. LMA® Protector™ in patients undergoing lap cholecystectomy.

Time Frame: 1.At insertion of the device | 2.At 5 minutes after insertion of the device. | 3.At 10 minutes after insertion of the device | 4.At the initiation of carboperitoneum | 5.At 5 minutes of carboperitoneum | 6.At 10 minutes of carboperitoneum | 7.At 20 minutes of carboperitoneum | 8.At the release of carboperitoneum | 9.5 minutes afterthe release of carboperitoneum | 10.10 minutes after the release of carboperitoneum

Secondary Outcomes

  • Comparison of(Airway resistance)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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