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Supraglottic Airway Device clinical trials

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NCT ID: NCT04652466 Not yet recruiting - Ultrasound Imaging Clinical Trials

Ultrasound Imaging to Validate I-gel Placement in pediatrıc Patients

Start date: December 15, 2020
Phase:
Study type: Observational

For nearly half a century, supraglottic airway devices (SGA) have been used in pediatric patients, which are more practical than face masks, facilitate oxygenation and ventilation without the need for endotracheal intubation, and less invasive than endotracheal tubes. I-Gel is a supraglottic airway management device introduced in 2007, made of a medical grade thermoplastic elastomer, designed to create a non-inflatable, anatomical seal in the pharyngeal, laryngeal and perilaryngeal structures that prevents compression trauma. Recently, the use of I-Gel has become popular in children undergoing surgery that does not require muscle relaxation. It is important to place an I-Gel in the most appropriate position in order to provide adequate ventilation and prevent complications such as mucosal injury, glottic ptosis, and gastric insufflation with potential aspiration. Successful placement is usually clinically assessed by a capnogram with endtidal carbon dioxide (ETCO2) value, visual examination and auscultation with appropriate chest elevation, absence of oropharyngeal leakage at 20 cm H2O peak inspiratory pressure. Although Fiberoptic Bronchoscope (FOB) is accepted as the preferred verification tool for direct visualization, some studies on I-Gel position using FOB reported that I-Gel placement should be repositioned in some children (12.8-49%). Ultrasonography (USG), which has recently entered the practice of upper airway examination, has become a valuable, non-invasive, simple and portable technology for evaluating airway management even in upper airway anatomy impaired by pathology or trauma. The aim of this study is to compare the use of USG with the FOB to evaluate I-Gel placement in pediatric patients. The primary endpoint is to compare the incidence of for I-Gel malposition between USG and FOB. Secondary endpoints are to find the correlation between I-Gel's USG and FOB-detected malposition and to determine the diagnostic performance of the USG.

NCT ID: NCT03643029 Not yet recruiting - General Anesthesia Clinical Trials

The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy

Start date: September 2018
Phase: N/A
Study type: Interventional

The supraglottic airway device (SAD) is currently widely used in patients undergoing general anaesthesia as a method of securing the airway. The usage of SAD does not require the patient to be paralysed prior to insertion, as opposed to an endotracheal tube. Five tests have been recommend to ensure that the SAD can be used for advanced procedure after a blind insertion. These tests however are not confirmed with visual validation and hence the confirmation of optimal position can be misleading. This study is conducted to validate by video laryngoscopy the five recommended tests for confirming the placement and efficacy of a SAD, thus enabling its safe application in institutions with limited availability of video laryngoscopes. Subjects for this study will consist of patients scheduled for procedures under general anaesthesia in the University of Malaya Medical Centre (UMMC) who are amenable to supraglottic airway management.