NCT05545163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

September 13, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

I-gelTechniqueStandardModifiedSimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and I-gel insertion techniques.

    1 minute

  • The trainee's baseline knowledge was assessed for the type 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.

    1 minute

  • The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel insertion technique.

    2 minutes

Other Outcomes (3)

  • 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

    2 minutes

  • The trainee's asked for the easy learning of I-gel insertion technique at his level of training.

    2 minutes

  • The trainee's asked for the preference of I-gel insertion technique in his practice at his level of training.

    1 minute

Study Arms (2)

I-gel with standard insertion technique

NO INTERVENTION

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

Modified jaw thrust I-gel insertion technique

EXPERIMENTAL

in this arm, trainees performed modified jaw thrust insertion technique

Device: I-gel with standard insertion technique

Interventions

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)

Also known as: Modified jaw thrust I-gel insertion technique
Modified jaw thrust I-gel insertion technique

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First year anaesthesia residents
  • Using adult mannequin

You may not qualify if:

  • Pediatric mannequin
  • Participant's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 21659406BACKGROUND
  • 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.

    PMID: 24220691BACKGROUND
  • 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.

    PMID: 28143389BACKGROUND
  • 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.

    PMID: 25800412BACKGROUND
  • 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.

    PMID: 17381577BACKGROUND
  • 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.

    PMID: 25788752BACKGROUND
  • 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.

    PMID: 32792739BACKGROUND

MeSH Terms

Conditions

HypersensitivityIge Responsiveness, Atopic

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • dileep kumar, MD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 19, 2022

Study Start

October 2, 2021

Primary Completion

October 2, 2021

Study Completion

October 2, 2021

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

The plan is to publish the study and consent has been taken from participants.

Shared Documents
SAP, CSR
Time Frame
Data is available
Access Criteria
Through Publication only
More information

Locations