The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa

Comparison Of The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa Wıth Flexible Bronchoscopy in Infants

Supraglottic airway devices (SGADs) are frequently preferred in surgical surgery for pediatric patients. i-gel LMA (laryngeal mask airway) and Ambu Aura-i LMA are the new generation supraglottic airway devices. The aim of this study was to compare airway trauma and postoperative complications due to i-gel and Ambu Aura in infants. In the study patients were divided into two groups performed on minor surgery ASA I (American Society of Anesthesiologists score) and 40 infants. After standard anesthesia i-Gel was placed into a group and Ambu Aura-i was placed to the other. Flexible bronchoscopy was performed at the end of surgery. Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.

Study Overview

• Status: Unknown
• Conditions: Mucosal Damage
• Intervention / Treatment: Device: I-gel; Device: Ambu aura i

Detailed Description

This study was conducted as prospective, randomized and double-blind study. After confirmation the approval from the Interventional Ethics Committee of the Bezmialem Vakif University, dated…. Number…., the study was started. Forty ASA I patients under the age of 1, with a body weight of more than 10 kg, without anatomical pathology in the upper airway with no general anesthesia within the last 2 weeks who underwent minor surgery (circumcision, inguinal hernia, undescended testis, hypospadias, etc.) by the Pediatric Surgery Clinic at Bezmialem Vakif University Medical School Hospital were included in the study. Patients who are older than 1 year of age and have a body weight of more than 10 kg, who have symptoms of upper or lower respiratory tract infection, who have more than one trial performed during the SADs placement, who are known and expected to be difficult airway, who has undergone surgery for more than 2 hours and patients who underwent emergency surgery were not included in the study.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Bezmialem Vakıf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA I
2. patients under the age of 1,
3. body weight of less than 10 kg
4. without anatomical pathology in the upper airway
5. no general anesthesia within the last 2 weeks who underwent minor surgery

Exclusion Criteria:

1. older than 1 year of age
2. body weight of more than 10 kg
3. symptoms of upper or lower respiratory tract infection
4. more than one trial performed during the SADs placement
5. known and expected to be difficult airway
6. undergone surgery for more than 2 hours and patients
7. underwent emergency surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I-gel LMA; After standard anesthesia i-Gel was placed into the patient.	Device: I-gel; After standard anesthesia i-Gel was placed into the patient; Other Names: I-gel laryngeal mask airway
Active Comparator: Ambu Aura-i; After standard anesthesia Ambu Aura-i was placed into the patient.	Device: Ambu aura i; After standard anesthesia ambu aura was placed into the patient; Other Names: Ambu aura i laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway trauma	4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding	up to 1 minute after extubation

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2019
• Primary Completion (Anticipated): September 15, 2019
• Study Completion (Anticipated): September 20, 2019

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Infant; I-gel; Flexible bronchoscopy; Laryngeal Mask; Ambu Aura i; Laryngopharyngeal damage
• Other Study ID Numbers: 71306642-S001

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
• product manufactured in and exported from the U.S.: No