Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults

Study Overview
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Brief Summary
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Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique

Detailed Description
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The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique. Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt. Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.

Official Title
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Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults

Conditions
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Airway Morbidity

Intervention / Treatment
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* Device: Supraglottic airway device (I-gel) insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II patients. Age 16 years to 60 years. Patient scheduled for elective surgical procedure. Exclusion Criteria: Gastroesophageal reflux disorders Obesity BMI more than 30. Pregnancy Reactive airway disease/asthma Patients with mallampati score III & IV Anticipated difficult airway Emergent surgery. Known allergic to isoflurane and propofol.

Ages Eligible for Study
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Minimum Age: 16 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard I-gel insertion technique<br>Investigator will apply the recommended (standard) I-gel insertion technique in patients | |
| Experimental: Modified I-gel insertion technique<br>Investigator will apply the modified (interventional) I-gel insertion technique in patients | Device: Supraglottic airway device (I-gel) insertion<br>* Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse airway events | All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse airway events | All study patients will be monitored forI-gel insertion complications such as an laryngospasm, hypoxemia (Sp02<92%) and trauma to surrounding airway structures will be observe as blood stained I-gel at removal. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management, I-gel, anaesthesia