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

Not Applicable

Completed

• Conditions: Airway Morbidity
• Interventions: Device: ProSeal Laryngeal mask airway; Device: Laryngeal Tube Suction- Disposable; Device: i-gel

• Registration Number: NCT02877940
• Lead Sponsor: Government Medical College, Haldwani

Brief Summary

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.

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2016-06
• Status Verified: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-20
• Last Update Submitted: 2016-08-20
• Study First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProSeal Laryngeal mask airway	ProSeal Laryngeal mask airway	ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.
Laryngeal Tube Suction- Disposable	Laryngeal Tube Suction- Disposable	LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries.
Group I	i-gel	i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries..

Primary Outcome Measures

Name	Time	Method
Number of Insertion attempts	10 mins

Secondary Outcome Measures

Name	Time	Method
Grading of insertion of device by Easy or Difficult	10 min	Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult.
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