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

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT05545163
Collaborator
(none)
14
1
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: I-gel with standard insertion technique
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 techniquesEach 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)
Primary Purpose:
Prevention
Official Title:
Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial
Actual Study Start Date :
Oct 2, 2021
Actual Primary Completion Date :
Oct 2, 2021
Actual Study Completion Date :
Oct 2, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. The ease of I-gel insertion was measured on the basis of number of I-gel insertion attempts. [5 minutes]

      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.

    2. The ease of I-gel insertion was measured on the basis of final I-gel insertion time taken duration. [5 minutes]

      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

    1. The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and I-gel insertion techniques. [1 minute]

      The questionnaire based trainee's asked for the prior information of the I-gel and other supraglottic airway device.

    2. The trainee's baseline knowledge was assessed for the type I-gel insertion techniques. [1 minute]

      The questionnaire based trainee's asked for the prior information for the type of I-gel insertion techniques.

    3. The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the I-gel. [1 minute]

      The questionnaire based trainee's asked for previous experience in using the I-gel device.

    4. The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel insertion technique. [2 minutes]

      The questionnaire based trainee's asked for the previous experience for modified jaw thrust I-gel insertion technique.

    Other Outcome Measures

    1. 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 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. The trainee's asked for the easy learning of I-gel insertion technique at his level of training. [2 minutes]

      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.

    3. The trainee's asked for the preference of I-gel insertion technique in his practice at his level of training. [1 minute]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • First year anaesthesia residents

    • Using adult mannequin

    Exclusion Criteria:
    • Pediatric mannequin

    • Participant's refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aga Khan University Hospital Karachi Sind Pakistan 74800

    Sponsors and Collaborators

    • Aga Khan University

    Investigators

    • Principal Investigator: dileep kumar, MD, Aga Khan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dileep Kumar, Assistant Professor, Aga Khan University
    ClinicalTrials.gov Identifier:
    NCT05545163
    Other Study ID Numbers:
    • 2021-6257-21893
    First Posted:
    Sep 19, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Dileep Kumar, Assistant Professor, Aga Khan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 19, 2022