Ultrasound Imaging to Validate I-gel Placement in pediatrıc Patients

Comparison of Fiberoptic Bronchoscopy and Ultrasound Imaging to Validate I-gel Placement in Pediatric Patients

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.

Study Overview

• Status: Unknown
• Conditions: Supraglottic Airway Device; Ultrasound Imaging; Fiberoptic Bronchoscopy
• Intervention / Treatment: Device: farukcicekci2

Detailed Description

The population of the study was created from the parents of pediatric patients who were scheduled for elective pediatric surgery under general anesthesia between December 2020 and February 2021 at Selcuk University Department of Anesthesiology and Reanimation. All patients were monitored with standard monitoring (ECG, non-invasive blood pressure, SpO2, ETCO2, Ppeak), after a minimum of 2 minutes of preoxygenation, mask ventilation was performed with 6-7% sevoflurane at the beginning of general anesthesia induction. Intravenous vein access was provided, and according to standard procedures; propofol 3.5 mg.kg 1, fentanyl 1 mg.kg 1 iv and remifentanil 0.1 mcg kg min 1 infusion was administered, but neuromuscular blocker was not used. The choice of the size of the I-Gel was selected according to the manufacturer's recommendations (size 1: 2-5 kg, size 1.5: 5 to 12 kg, size 2: 10 to 25 kg). Adequate anesthesia depth was confirmed by loss of eyelash reflex, symmetrical small pupils and absence of swallowing, and was guided gently along the hard palate by the 1st anesthesiologist until resistance was felt, with the I-Gel opening facing the applicator. If the patient did not tolerate the insertion of the I-Gel, an extra dose of fentanyl up to a maximum of 0.5 mcg / kg in total was administered. However, if the insertion attempt was still not tolerated, or if the capnography curve was not obtained and there was an audible leak, the technique was considered to be unsuccessful, and another SGA was then placed in the airway. If this change was not tolerated, endotracheal intubation was initiated by applying neuromuscular blocker and these were recorded.

USG examination of the neck was performed by the second anesthesiologist using an 8-18 MHz linear probe Esaote Imaging was done in three planes (Transverse plane between hyoid bone and thyroid bone, Transverse plane of the lateral suprasternal notch and Parasagittal plane of pharynx and larynx) the USG score was assigned to the deployment view using a modification of the criteria proposed.

The fiberoptic bronchoscope was passed through I-Gel until the glottis image was obtained.Optimal placement was defined as the end of the I-Gel behind the arytenoids, with a visible epiglottis, with or without folding to the airway, and the vocal cords are visible when the FOB is advanced under the epiglottis.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Faruk Cicekci; Phone Number: 00905057649235; Email: farukcicekci@yahoo.com

Study Locations

• Turkey
  • Konya, Turkey, 42250
    • Selcuk University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation between I-Gel's USG and FOB	to find the correlation between I-Gel's USG and FOB-detected malposition and to determine the diagnostic performance of the USG.	1 months

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Faruk Cicekci, Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: farukcicekci2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No