LMA Fixation Method
- Conditions
- Fixation Device; Complications
- Interventions
- Device: Proseal Laryngeal mask fixation
- Registration Number
- NCT05433740
- Lead Sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
-
Undergoing urologic surgery using LMA
-
ASA Physical Status I-III
-
Mallampati score I-II
- 18 years
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I: Adjustable ligament Proseal Laryngeal mask fixation 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.
- Primary Outcome Measures
Name Time Method laryngeal mask correct insertion and than fixation intraoperative 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey
🇹🇷Altındağ, Ankara, Turkey