Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists

Study Overview
=================
Brief Summary
-----------------
The primary objective of study was to compare insertion ease by modified I-gel jaw thrust insertion technique and standard I-gel insertion technique on the basis of I-gel insertion attempts and I-gel insertion time duration. The secondary objective of study was to analyse the impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique at the basis of learning method and practical adaptability. Hypothesis: The modified I-gel jaw thrust insertion technique is easy to understand and practice than the standard I-gel insertion technique at the beginning of airway management training among the novice anesthesiologists.

Detailed Description
-----------------
I-gel insertion attempts are the number of I-gel insertion attempts with each study's insertion technique. The 10 insertion attempts allowed to performed with each insertion technique by trainees. I-gel insertion time duration was the time taken to complete I-gel insertion; from the holding of device till the confirmation of chest movement (artificial lung inflation in manikin). The correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques were assessed by asking from participant's questionnaire based at the start of study. The trainees were asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly).

Official Title
-----------------
Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial

Conditions
-----------------
Training Group, Sensitivity, Igel

Intervention / Treatment
-----------------
* Device: I-gel with standard insertion technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First year anaesthesia residents Using adult mannequin Exclusion Criteria: Pediatric mannequin Participant's refusal
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each novice resident will place ten times I-gel insertion with each insertion technique in randomized cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place I-gel with standard insertion technique and other group will place by modified jaw thrust I-gel insertion technique, then after, the groups will switch over with concerned insertion techniques
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: I-gel with standard insertion technique<br>in this arm, trainees performed the standard I-gel insertion technique | |
| Experimental: Modified jaw thrust I-gel insertion technique<br>in this arm, trainees performed modified jaw thrust insertion technique | Device: I-gel with standard insertion technique<br>* Standard I-gel insertion technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down the manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate. Then I-gel slided downwards and backwards along hard palate with a continuous but gentle push until a definitive resistance is felt) Modified jaw thrust technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate with gently advancing into oropharynx. Then after, I-gel left in oral cavity and both hands used to thrust jaw by lifting angle of mandible with little fingers and other fingers to stabilise jaw. And, at this point, both hand's thumbs used to apply balance force from I-gel stem head towards final placement position by looking at integral bite block mark at incisor teeth level)<br>* Other names: Modified jaw thrust I-gel insertion technique;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of I-gel insertion was measured on the basis of number of I-gel insertion attempts. | Ease of I-gel insertion in mannequin mouth was measured by performing the 10 times insertion of I-gel with both study techniques in mannequin mouth by trainees. | 5 minutes | 
| The ease of I-gel insertion was measured on the basis of final I-gel insertion time taken duration. | The total time duration of final I-gel insertion confirmation in mannequin mouth was recorded. The time duration counting was started from I-gel holding in operator's hand to the confirmed successful insertion in mannequin mouth. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and I-gel insertion techniques. | The questionnaire based trainee's asked for the prior information of the I-gel and other supraglottic airway device. | 1 minute | 
| The trainee's baseline knowledge was assessed for the type I-gel insertion techniques. | The questionnaire based trainee's asked for the prior information for the type of I-gel insertion techniques. | 1 minute | 
| The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the I-gel. | The questionnaire based trainee's asked for previous experience in using the I-gel device. | 1 minute | 
| The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel insertion technique. | The questionnaire based trainee's asked for the previous experience for modified jaw thrust I-gel insertion technique. | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
I-gel, Technique, Standard, Modified, Simulation