Ultrasound Imaging to Validate I-gel Placement in pediatrıc Patients

NCT04652466 | Unknown

• 1 other identifier: farukcicekci2
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound Imaging; Supraglottic Airway Device; Fiberoptic Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• the incidence of for I-Gel malposition between USG and FOB

  to compare the incidence of for I-Gel malposition between USG and FOB.

  1 months

Secondary Outcomes (1)

• the correlation between I-Gel's USG and FOB

  1 months

Interventions

farukcicekci2 DEVICE

To compare the incidence of for I-Gel malposition between USG and FOB, and to find the correlation between I-Gel's USG and FOB-detected malposition

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The pediatric patients who were scheduled to undergo surgery under general anesthesia placed I-Gel for airway were enrolled in the study.

You may qualify if:

• Undergoing elective pediatric surgery
• American Society of Anesthesiologists (ASA) status I-II
• Placed I-Gel for airway

You may not qualify if:

• Patients with head and neck anatomical malformation and airway congenital defects

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University, School of Medicine

Konya, 42250, Turkey (Türkiye)

Location

Study Officials

• Faruk Cicekci

  Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faruk Cicekci

CONTACT

00905057649235; farukcicekci@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: December 15, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 15, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)