Comparison of ProSeal Laryngeal Mask Airway, LTS-D and I-gel in Mechanically Ventilated Patients

A Randomized Controlled Trial Comparing Proseal Laryngeal Mask Airway, I-gel Airway and Laryngeal Tube Suction-D in Mechanically Ventilated Patients

The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.

Study Overview

• Status: Completed
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: ProSeal Laryngeal mask airway; Device: Laryngeal Tube Suction- Disposable; Device: i-gel

Detailed Description

The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.

Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.

Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.

Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.

The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anaesthesiologists (ASA) class I/II.
• Age 20-60years of either sex.
• Weight between 40-60 kg of either sex.
• Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.

Exclusion Criteria:

• Patient with risk factors for difficult airway. (Mouth opening of <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
• Any known pulmonary and cardiovascular diseases.
• Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ProSeal Laryngeal mask airway; ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.	Device: ProSeal Laryngeal mask airway; ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.
Active Comparator: Laryngeal Tube Suction- Disposable; LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries.	Device: Laryngeal Tube Suction- Disposable; LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.
Active Comparator: Group I; i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries..	Device: i-gel; i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Insertion attempts	10 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grading of insertion of device by Easy or Difficult	Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult.	10 min
Time taken for placement of device		10 min
Airway sealing pressure		10 min
Number of attempts of gastric tube placement		20 min
Complication		120 min

Collaborators and Investigators

• Sponsor: Government Medical College, Haldwani
• Investigators: Principal Investigator: Geeta Bhandari, MD, Professor

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 20, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 20, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: i-gel; ProSeal LMA; LTS-D
• Other Study ID Numbers: 203/GMC/IEC/04/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO