Clinical trial NCT05433740: LMA Fixation Method
Official title: Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fixation Device; Complications
Keywords: laryngeal mask airway
fixation
fiberoptic bronchoscope
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I: Adjustable ligament or Group II, adhesive tape
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing urologic surgery using LMA
* ASA Physical Status I-III
* Mallampati score I-II

  * 18 years

Exclusion Criteria:

* Patients who did not want to participate in the study
* Restricted mouth opening
* BMI ≥ 35 kg/m2
* Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal hernia, history of previous gastric surgery, GIS motility disorder)

Primary outcomes:
measure: laryngeal mask correct insertion and than fixation
timeFrame: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
Secondary outcomes:
measure: Evaluation of successful laryngeal mask placement with a fiberoptic bronchoscope (FOB)
timeFrame: intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey
state: Ankara
Study officials:
References:
citation: Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.
citation: Garc'a-Aguado R. Fixation of the ProSeal Laryngeal Mask Airway with a gauze bandage. Anaesthesia. 2005 Jul;60(7):726. doi: 10.1111/j.1365-2044.2005.04277.x. No abstract available.
citation: Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.