NCT05433740

LMA Fixation Method

Completed NA Last updated 3 November 2022

What this trial tests

NA trial testing Proseal Laryngeal mask fixation in Fixation Device; Complications in 116 participants. Completed in 30 September 2022.

Timeline

30 August 2022

Primary endpoint
3 September 2022

30 September 2022

Quick facts

Lead sponsor	Diskapi Yildirim Beyazit Education and Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	116
Start date	30 August 2022
Primary completion	3 September 2022
Estimated completion	30 September 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Proseal Laryngeal mask fixation

Conditions studied

• Fixation Device; Complications — all drugs for Fixation Device; Complications →

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Who can join

Adults 18 to 88, any sex, with Fixation Device; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.

PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.

SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Two Different Methods for ProSeal^TM Laryngeal Mask Fixation.
   Atar F, Keskin G, Karaca Akaslan F, Tıraş Y, et al · · 2023 · PMID 37876165 · DOI 10.4274/tjar.2023.231225