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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05544838
Other study ID # 2022-6256-22361
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2021
Est. completion date October 2, 2021

Study information

Verified date September 2022
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date October 2, 2021
Est. primary completion date October 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - First year anaesthesia trainee - Using adult mannequin Exclusion Criteria: - Paediatric mannequin - Participant's refusal

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Pakistan Aga Khan University Hospital Karachi Sind

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. Review. — View 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. — View 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. doi: 05.2012/JCPSP.275279. Erratum in: J Coll Physicians Surg Pak. 2012 Jun;22(6):411. — View 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. — View 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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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