LMA Fixation Method

Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation

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.

Study Overview

• Status: Completed
• Conditions: Fixation Device; Complications
• Intervention / Treatment: Device: Proseal Laryngeal mask fixation

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Altındağ, Ankara, Turkey, 06000
      • University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I: Adjustable ligament; In the adjustable ligament method, binding tape with a button at one end and button holes along the band was wrapped around the outer end of the bite-block section of the device. The ends of the tape were then passed over the outer end of the bite block between two tubes and adjusted at or above the ear level (except neck veins), and fixed by inserting the button through the appropriate hole.	Device: Proseal Laryngeal mask fixation; fixation with Proseal Laryngeal mask adjustable ligament
NO_INTERVENTION: Group II: Adhesive tape; The laryngeal mask was fixed using the standard method using adhesive tape.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2022
• Primary Completion (ACTUAL): September 3, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (ACTUAL): June 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: laryngeal mask airway; fixation; fiberoptic bronchoscope
• Other Study ID Numbers: 04.04.2022 134/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No