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

Primary Purpose

Training Group, Sensitivity, Igel

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
I-gel with standard insertion technique
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Training Group, Sensitivity focused on measuring I-gel, Technique, Standard, Modified, Simulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • First year anaesthesia residents
  • Using adult mannequin

Exclusion Criteria:

  • Pediatric mannequin
  • Participant's refusal

Sites / Locations

  • Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

I-gel with standard insertion technique

Modified jaw thrust I-gel insertion technique

Arm Description

in this arm, trainees performed the standard I-gel insertion technique

in this arm, trainees performed modified jaw thrust insertion technique

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 13, 2022
Last Updated
September 14, 2022
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT05545163
Brief Title
Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists
Acronym
I-gel
Official Title
Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2021 (Actual)
Primary Completion Date
October 2, 2021 (Actual)
Study Completion Date
October 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Training Group, Sensitivity, Igel
Keywords
I-gel, Technique, Standard, Modified, Simulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-gel with standard insertion technique
Arm Type
No Intervention
Arm Description
in this arm, trainees performed the standard I-gel insertion technique
Arm Title
Modified jaw thrust I-gel insertion technique
Arm Type
Experimental
Arm Description
in this arm, trainees performed modified jaw thrust insertion technique
Intervention Type
Device
Intervention Name(s)
I-gel with standard insertion technique
Other Intervention Name(s)
Modified jaw thrust I-gel insertion technique
Intervention Description
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)
Primary Outcome Measure Information:
Title
The ease of I-gel insertion was measured on the basis of number of I-gel insertion attempts.
Description
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.
Time Frame
5 minutes
Title
The ease of I-gel insertion was measured on the basis of final I-gel insertion time taken duration.
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and I-gel insertion techniques.
Description
The questionnaire based trainee's asked for the prior information of the I-gel and other supraglottic airway device.
Time Frame
1 minute
Title
The trainee's baseline knowledge was assessed for the type I-gel insertion techniques.
Description
The questionnaire based trainee's asked for the prior information for the type of I-gel insertion techniques.
Time Frame
1 minute
Title
The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the I-gel.
Description
The questionnaire based trainee's asked for previous experience in using the I-gel device.
Time Frame
1 minute
Title
The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel insertion technique.
Description
The questionnaire based trainee's asked for the previous experience for modified jaw thrust I-gel insertion technique.
Time Frame
2 minutes
Other Pre-specified Outcome Measures:
Title
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
Description
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.
Time Frame
2 minutes
Title
The trainee's asked for the easy learning of I-gel insertion technique at his level of training.
Description
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.
Time Frame
2 minutes
Title
The trainee's asked for the preference of I-gel insertion technique in his practice at his level of training.
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First year anaesthesia residents Using adult mannequin Exclusion Criteria: Pediatric mannequin Participant's refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dileep kumar, MD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.aku.edu
Citations:
PubMed Identifier
21659406
Citation
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.
Results Reference
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PubMed Identifier
24220691
Citation
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.
Results Reference
background
PubMed Identifier
28143389
Citation
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.
Results Reference
background
PubMed Identifier
25800412
Citation
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.
Results Reference
background
PubMed Identifier
17381577
Citation
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.
Results Reference
background
PubMed Identifier
25788752
Citation
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.
Results Reference
background
PubMed Identifier
32792739
Citation
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.
Results Reference
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Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists

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