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

Simulation Based Comparison Of Standard Versus Rotational Laryngeal Mask Airway Insertion Technique In Novice Anesthesiologists. A Randomised Control Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Training Group, Sensitivity
• Intervention / Treatment: Device: LMA insertion with standard technique

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)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 74800
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First year anaesthesia trainee
• Using adult mannequin

Exclusion Criteria:

• Paediatric mannequin
• Participant's refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: LMA with standard insertion technique; 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.
Experimental: Rotational LMA insertion technique; 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.	Device: LMA insertion with standard technique; 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.; Other Names: Rotational LMA insertion technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minute
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.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 minute
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.	1 minute
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.	1 minute
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.	2 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 minutes
The trainee's asked for the easy learning of LMA insertion technique at his level of training.	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.	2 minutes
The trainee's asked for the preference of LMA 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 LMA insertion technique like standard or rotational LMA insertion at his level of training year.	1 minute

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2021
• Primary Completion (Actual): October 2, 2021
• Study Completion (Actual): October 2, 2021

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Simulation; Standard; Technique; LMA; Rotational
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2022-6256-22361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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