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

Training Group, Sensitivity Clinical Trial

— I-gel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545163
• Other study ID #: 2021-6257-21893
• Status: Completed
• Phase: N/A
• Start date: October 2, 2021
• Est. completion date: October 2, 2021

Study information

• Verified date: September 2022
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2, 2021
• Est. primary completion date: October 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First year anaesthesia residents

• Using adult mannequin

Exclusion Criteria:

• Pediatric mannequin

• Participant's refusal

Related Conditions & MeSH terms

• Hypersensitivity
• Igel
• Training Group, Sensitivity

Intervention

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)

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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