LMA Fixation Method

Fixation Device; Complications Clinical Trial

Official title:

Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433740
• Other study ID #: 04.04.2022 134/13
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 30, 2022
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fixation Device; Complications

Intervention

Device:
• Proseal Laryngeal mask fixation
fixation with Proseal Laryngeal mask adjustable ligament

Locations

Country	Name	City	State
Turkey	University of Medical Science, Yildirim Beyazit Training and Research Hospital, Ankara, Turkey	Altindag	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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. Review. — View Citation

Garc'a-Aguado R. Fixation of the ProSeal Laryngeal Mask Airway with a gauze bandage. Anaesthesia. 2005 Jul;60(7):726. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laryngeal mask correct insertion and than fixation	The placement and fixation of the laryngeal mask will be evaluated by measuring the end-tidal carbon dioxide value with the aid of a capnogram, the formation of appropriate chest extension, and the absence of audible leakage at 20 cm H2O peak inspiratory pressure.	intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)
Secondary	Evaluation of successful laryngeal mask placement with a fiberoptic bronchoscope (FOB)	To evaluate the best fiberoptic bronchoscopic view while insertion of proseal laryngeal mask	intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)