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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-18

Study Completion Date

2019-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mucosal Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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I-gel LMA

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

Group Type ACTIVE_COMPARATOR

I-gel

Intervention Type DEVICE

After standard anesthesia i-Gel was placed into the patient

Ambu Aura-i

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

Group Type ACTIVE_COMPARATOR

Ambu aura i

Intervention Type DEVICE

After standard anesthesia ambu aura was placed into the patient

Interventions

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I-gel

After standard anesthesia i-Gel was placed into the patient

Intervention Type DEVICE

Ambu aura i

After standard anesthesia ambu aura was placed into the patient

Intervention Type DEVICE

Other Intervention Names

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I-gel laryngeal mask airway Ambu aura i laryngeal mask airway

Eligibility Criteria

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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

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No