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Completed

NCT Number: NCT05433740

LMA Fixation Method

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.

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Key information

Conditions

Fixation Device; Complications

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Altındağ, Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Proseal Laryngeal mask fixation

Device

fixation with Proseal Laryngeal mask adjustable ligament

Primary outcomes

  1. laryngeal mask correct insertion and than fixation

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Two Different Methods for ProsealTM Laryngeal Mask Fixation

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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