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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Airway Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ProSeal Laryngeal mask airway

ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.

Group Type ACTIVE_COMPARATOR

ProSeal Laryngeal mask airway

Intervention Type DEVICE

ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.

Laryngeal Tube Suction- Disposable

LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries.

Group Type ACTIVE_COMPARATOR

Laryngeal Tube Suction- Disposable

Intervention Type DEVICE

LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.

Group I

i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries..

Group Type ACTIVE_COMPARATOR

i-gel

Intervention Type DEVICE

i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

Interventions

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ProSeal Laryngeal mask airway

ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.

Intervention Type DEVICE

Laryngeal Tube Suction- Disposable

LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.

Intervention Type DEVICE

i-gel

i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes