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

NCT04062747 | Unknown DMC

• 1 other identifier: 71306642-S001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mucosal Damage

Keywords

Laryngeal Mask; I-gel; Ambu Aura i; Flexible bronchoscopy; Laryngopharyngeal damage; Infant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

I-gel LMA

ACTIVE COMPARATOR

After standard anesthesia i-Gel was placed into the patient.

Device: I-gel

Ambu Aura-i

ACTIVE COMPARATOR

After standard anesthesia Ambu Aura-i was placed into the patient.

Device: Ambu aura i

Interventions

I-gel DEVICE

After standard anesthesia i-Gel was placed into the patient

Also known as: I-gel laryngeal mask airway

I-gel LMA

Ambu aura i DEVICE

After standard anesthesia ambu aura was placed into the patient

Also known as: Ambu aura i laryngeal mask airway

Ambu Aura-i

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Sinan Yılmaz, Instructor

CONTACT

+905324563023; siyilmaz@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 20, 2019
• Study Start: May 18, 2019
• Primary Completion: September 15, 2019
• Study Completion: September 20, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)