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LMA Fixation Method

Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05433740
Enrollment
116
Registered
2022-06-27
Start date
2022-08-30
Completion date
2022-09-30
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fixation Device; Complications

Keywords

laryngeal mask airway, fixation, fiberoptic bronchoscope

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.

Interventions

DEVICEProseal Laryngeal mask fixation

fixation with Proseal Laryngeal mask adjustable ligament

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

undergoing urologic surgery using LMA with ASA Physical Status I-III, Mallampati score I-II, and \>18 years of age

Intervention model description

Group I: Adjustable ligament or Group II, adhesive tape

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
laryngeal mask correct insertion and than fixationintraoperative period (From the insertion of the laryngeal mask airway to its removal at the end of the procedure)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.

Secondary

MeasureTime frameDescription
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)To evaluate the best fiberoptic bronchoscopic view while insertion of proseal laryngeal mask

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026