LMA Fixation Method

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433740
Collaborator
(none)
115
2
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Proseal Laryngeal mask fixation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group I: Adjustable ligament or Group II, adhesive tapeGroup I: Adjustable ligament or Group II, adhesive tape
Masking:
Single (Participant)
Masking Description:
undergoing urologic surgery using LMA with ASA Physical Status I-III, Mallampati score I-II, and >18 years of age
Primary Purpose:
Other
Official Title:
Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  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)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 88 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Funda Atar, expert doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05433740
Other Study ID Numbers:
  • 04.04.2022 134/13
First Posted:
Jun 27, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Funda Atar, expert doctor, Diskapi Yildirim Beyazit Education and Research Hospital

Study Results

No Results Posted as of Jul 20, 2022