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

Bezmialem Vakif University

Status: Unknown

Conditions: Mucosal Damage

Treatments: Device: Ambu aura i; Device: I-gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04062747

71306642-S001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

I-gel LMA

Active Comparator group

Description:

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

Treatment:

Device: I-gel

Ambu Aura-i

Active Comparator group

Description:

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

Treatment:

Device: Ambu aura i