LMA Fixation Method

NCT05433740 | Completed

• 1 other identifier: 04.04.2022 134/13
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Fixation Device; Complications

Keywords

laryngeal mask airway; fixation; fiberoptic bronchoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of successful laryngeal mask placement with a fiberoptic bronchoscope (FOB)

  intraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)

Study Arms (2)

Group I: Adjustable ligament

EXPERIMENTAL

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

Group II: Adhesive tape

NO INTERVENTION

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

Interventions

Proseal Laryngeal mask fixation DEVICE

fixation with Proseal Laryngeal mask adjustable ligament

Group I: Adjustable ligament

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

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

Altındağ, Ankara, 06000, Turkey (Türkiye)

Location

Related 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/s12663-009-0025-8. Epub 2009 Aug 11.

  PMID: 23139483 RESULT

• 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.

  PMID: 15960739 RESULT

• 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.

  PMID: 16103390 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: undergoing urologic surgery using LMA with ASA Physical Status I-III, Mallampati score I-II, and \>18 years of age
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: expert doctor

Model Details: Group I: Adjustable ligament or Group II, adhesive tape

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 27, 2022
• Study Start: August 30, 2022
• Primary Completion: September 3, 2022
• Study Completion: September 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)