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

Study Overview
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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.

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.

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

Conditions
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Airway Morbidity

Intervention / Treatment
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* Device: ProSeal Laryngeal mask airway
* Device: Laryngeal Tube Suction- Disposable
* Device: i-gel


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProSeal LMA, LTS-D, i-gel