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Completed

NCT Number: NCT05545163

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

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.

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Key information

Conditions

Training Group, Sensitivity Hypersensitivity Ige Responsiveness, Atopic Igel Immune System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

About this study

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First year anaesthesia residents
  • Using adult mannequin

Exclusion criteria

  • Pediatric mannequin
  • Participant's refusal

Treatment and study plan

I-gel with standard insertion technique

Device

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

Primary outcomes

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

    Time frame: 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.

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 2 minutes

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

Other outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Acronym: I-gel

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2022
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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