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

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

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.

Study Overview

• Status: Completed
• Conditions: Training Group, Sensitivity; Igel
• Intervention / Treatment: Device: I-gel with standard insertion technique

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).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 74800
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First year anaesthesia residents
• Using adult mannequin

Exclusion Criteria:

• Pediatric mannequin
• Participant's refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: I-gel with standard insertion technique; in this arm, trainees performed the standard I-gel insertion technique
Experimental: Modified jaw thrust I-gel insertion technique; in this arm, trainees performed modified jaw thrust insertion technique	Device: I-gel with standard insertion technique; 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); 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The trainee's asked for the choice of I-gel insertion technique at the start of learning airway management using the I-gel at his level	The questionnaire based trainee's asked for the choice of type of I-gel insertion technique such as standard or modified jaw thrust insertion at start of learning the airway management at his level of training year.	2 minutes
The trainee's asked for the easy learning of I-gel insertion technique at his level of training.	The questionnaire based trainee's asked for his experience of easy learning of type of I-gel insertion technique such as standard or modified jaw thrust insertion at his level of training year.	2 minutes
The trainee's asked for the preference of I-gel insertion technique in his practice at his level of training.	The questionnaire based trainee's asked for his preference to practice most of the time for the type of I-gel insertion technique like standard or modified jaw thrust insertion at his level of training year.	1 minute

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General Publications

• Boet S, Borges BC, Naik VN, Siu LW, Riem N, Chandra D, Bould MD, Joo HS. Complex procedural skills are retained for a minimum of 1 yr after a single high-fidelity simulation training session. Br J Anaesth. 2011 Oct;107(4):533-9. doi: 10.1093/bja/aer160. Epub 2011 Jun 9.
• Kennedy CC, Cannon EK, Warner DO, Cook DA. Advanced airway management simulation training in medical education: a systematic review and meta-analysis. Crit Care Med. 2014 Jan;42(1):169-78. doi: 10.1097/CCM.0b013e31829a721f.
• Sun Y, Pan C, Li T, Gan TJ. Airway management education: simulation based training versus non-simulation based training-A systematic review and meta-analyses. BMC Anesthesiol. 2017 Feb 1;17(1):17. doi: 10.1186/s12871-017-0313-7.
• Lee DW, Kang MJ, Kim YH, Lee JH, Cho KW, Kim YW, Cho JH, Kim YS, Hong CK, Hwang SY. Performance of intubation with 4 different airway devices by unskilled rescuers: manikin study. Am J Emerg Med. 2015 May;33(5):691-6. doi: 10.1016/j.ajem.2015.03.006. Epub 2015 Mar 12.
• Jackson KM, Cook TM. Evaluation of four airway training manikins as patient simulators for the insertion of eight types of supraglottic airway devices. Anaesthesia. 2007 Apr;62(4):388-93. doi: 10.1111/j.1365-2044.2007.04983.x.
• Kumar D, Hayat M, Khan A. i-gel insertion with modified jaw thrust technique. Indian J Anaesth. 2015 Feb;59(2):132-3. doi: 10.4103/0019-5049.151383. No abstract available.
• Bhardwaj M, Singhal SK, Rashmi, Dahiya A. A prospective randomised trial to compare three insertion techniques for i-gel placement: Standard, reverse, and rotation. Indian J Anaesth. 2020 Jul;64(7):618-623. doi: 10.4103/ija.IJA_937_19. Epub 2020 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2021
• Primary Completion (Actual): October 2, 2021
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Simulation; I-gel; Standard; Technique; Modified
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2021-6257-21893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The plan is to publish the study and consent has been taken from participants.
• IPD Sharing Time Frame: Data is available
• IPD Sharing Access Criteria: Through Publication only
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No