NCT05544838

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

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
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

September 13, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

LMATechniqueStandardRotationalSimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

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

    1 minute

  • 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.

    1 minute

  • The trainee's baseline knowledge was assessed for the studied Rotational LMA insertion technique.

    2 minutes

Other Outcomes (3)

  • 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.

    2 minutes

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

    2 minutes

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

    1 minute

Study Arms (2)

LMA with standard insertion technique

NO INTERVENTION

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 technique

EXPERIMENTAL

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

Interventions

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.

Also known as: Rotational LMA insertion technique
Rotational LMA insertion technique

Eligibility Criteria

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

You may qualify if:

  • First year anaesthesia trainee
  • Using adult mannequin

You may not qualify if:

  • Paediatric 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 (6)

  • 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.

    PMID: 22538029BACKGROUND
  • 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.

    PMID: 29766036BACKGROUND
  • 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
  • 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
  • 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.

  • D K, C K. Simulation-Based Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion Techniques in Novice Anesthesiologists: A Randomized Controlled Crossover Trial. Anesthesiol Res Pract. 2025 Dec 31;2025:7850095. doi: 10.1155/anrp/7850095. eCollection 2025.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

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 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

October 2, 2021

Primary Completion

October 2, 2021

Study Completion

October 2, 2021

Last Updated

September 16, 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