LMA Fixation Method

NCT ID: NCT05433740

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2022-09-30

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.

Conditions

Fixation Device; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Proseal Laryngeal mask fixation

Intervention Type: DEVICE

fixation with Proseal Laryngeal mask adjustable ligament

Group II: Adhesive tape

The laryngeal mask was fixed using the standard method using adhesive tape.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Proseal Laryngeal mask fixation

fixation with Proseal Laryngeal mask adjustable ligament

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Funda Atar

expert doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Altındağ, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 23139483 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15960739 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16103390 (View on PubMed)

Other Identifiers

04.04.2022 134/13

Identifier Type: -

Identifier Source: org_study_id