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Simulated Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion in Novice Anaesthesiologists. (LMA)

Primary Purpose

Training Group, Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
LMA insertion with standard 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 LMA, Technique, Standard, Rotational, Simulation

Eligibility Criteria

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

Inclusion Criteria:

  • First year anaesthesia trainee
  • Using adult mannequin

Exclusion Criteria:

  • Paediatric 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

LMA with standard insertion technique

Rotational LMA insertion technique

Arm Description

Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed.

Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side.

Outcomes

Primary Outcome Measures

The ease of LMA insertion was measured on the basis of number of LMA insertion attempts.
Ease of LMA insertion in mannequin mouth was measured by performing the 10 times insertion of LMA with both study techniques in mannequin mouth by trainees.
The ease of LMA insertion was measured on the basis of final LMA insertion time taken duration.
The total time duration of final LMA insertion confirmation in mannequin mouth was recorded. The time duration counting was started from LMA 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 LMA insertion techniques.
The questionnaire based trainee's asked for the prior information of the LMA and other supraglottic airway devices.
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the LMA.
The questionnaire based trainee's asked for previous experience in using the LMA device.
The trainee's baseline knowledge was assessed for the studied Rotational LMA insertion technique.
The questionnaire based trainee's asked for the previous experience for rotational LMA 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
NCT05544838
Brief Title
Simulated Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion in Novice Anaesthesiologists.
Acronym
LMA
Official Title
Simulation Based Comparison Of Standard Versus Rotational Laryngeal Mask Airway 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 standard and rotational LMA insertion technique on basis of LMA insertion attempts and insertion time duration. The secondary objective of study was to analyse impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with ease of both insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique on basis of learning method and practical adaptability. Hypothesis: The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists. Hypothesis: The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists.
Detailed Description
LMA insertion attempts are the number of LMA insertion attempts with each study's insertion technique. The 10 insertion attempts will be performed with each insertion technique by trainees. LMA insertion time duration is the time taken to complete LMA insertion; from the holding of device till the confirmation of chest movement (artificial lungs 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 will be asked by participant's through the questionnaire at the start of study. The trainees will be 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
Keywords
LMA, Technique, Standard, Rotational, 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 LMA insertion with each insertion technique in randomised cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place LMA with standard insertion technique and other group will place by rotational LMA insertion technique, then after, the groups will switch over with concerned insertion techniques
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LMA with standard insertion technique
Arm Type
No Intervention
Arm Description
Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed.
Arm Title
Rotational LMA insertion technique
Arm Type
Experimental
Arm Description
Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side.
Intervention Type
Device
Intervention Name(s)
LMA insertion with standard technique
Other Intervention Name(s)
Rotational LMA insertion technique
Intervention Description
Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed. Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side.
Primary Outcome Measure Information:
Title
The ease of LMA insertion was measured on the basis of number of LMA insertion attempts.
Description
Ease of LMA insertion in mannequin mouth was measured by performing the 10 times insertion of LMA with both study techniques in mannequin mouth by trainees.
Time Frame
5 minute
Title
The ease of LMA insertion was measured on the basis of final LMA insertion time taken duration.
Description
The total time duration of final LMA insertion confirmation in mannequin mouth was recorded. The time duration counting was started from LMA 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 LMA insertion techniques.
Description
The questionnaire based trainee's asked for the prior information of the LMA and other supraglottic airway devices.
Time Frame
1 minute
Title
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
Description
The trainee's baseline knowledge was assessed for the type LMA 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 LMA.
Description
The questionnaire based trainee's asked for previous experience in using the LMA device.
Time Frame
1 minute
Title
The trainee's baseline knowledge was assessed for the studied Rotational LMA insertion technique.
Description
The questionnaire based trainee's asked for the previous experience for rotational LMA insertion technique.
Time Frame
2 minutes
Other Pre-specified Outcome Measures:
Title
The trainee's asked for the choice of LMA insertion technique at the start of learning airway management using the LMA device at his level.
Description
The questionnaire based trainee's asked for the choice of type of LMA insertion technique such as standard or rotational LMA 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 LMA insertion technique at his level of training.
Description
The questionnaire based trainee's asked for his experience of easy learning of type of LMA insertion technique such as standard or rotational LMA insertion at his level of training year.
Time Frame
2 minutes
Title
The trainee's asked for the preference of LMA 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 LMA insertion technique like standard or rotational LMA 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 trainee Using adult mannequin Exclusion Criteria: Paediatric mannequin Participant's refusal
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
http://www.aku.edu
Citations:
PubMed Identifier
22538029
Citation
Kumar D, Khan M, Ishaq M. Rotational vs. standard smooth laryngeal mask airway insertion in adults. J Coll Physicians Surg Pak. 2012 May;22(5):275-9. Erratum In: J Coll Physicians Surg Pak. 2012 Jun;22(6):411.
Results Reference
background
PubMed Identifier
29766036
Citation
Komasawa N, Berg BW. Simulation-based Airway Management Training for Anesthesiologists - A Brief Review of its Essential Role in Skills Training for Clinical Competency. J Educ Perioper Med. 2017 Oct 1;19(4):E612. eCollection 2017 Oct-Dec.
Results Reference
background
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
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
33263351
Citation
Liti A, Giusti GD, Gili A, Giontella M, Dell'Omo S, Camerlingo V, Fronteddu A, Galazzi A, Bambi S. Insertion of four different types of supraglottic airway devices by emergency nurses. A mannequin-based simulation study. Acta Biomed. 2020 Nov 30;91(12-S):e2020016. doi: 10.23750/abm.v91i12-S.10832.
Results Reference
result

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Simulated Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion in Novice Anaesthesiologists.

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