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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062747
Enrollment
40
Registered
2019-08-20
Start date
2019-05-18
Completion date
2019-09-20
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucosal Damage

Keywords

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

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.

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.

Interventions

DEVICEI-gel

After standard anesthesia i-Gel was placed into the patient

After standard anesthesia ambu aura was placed into the patient

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
airway traumaup to 1 minute after extubation4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding

Countries

Turkey (Türkiye)

Contacts

Primary ContactSinan Yılmaz, Instructor
siyilmaz@bezmialem.edu.tr+905324563023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026