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

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ClinicalTrials.gov Identifier: NCT04062747
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Mucosal Damage Device: I-gel Device: Ambu aura i Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Comparison Of The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa Wıth Flexible Bronchoscopy in Infants
Actual Study Start Date : May 18, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 20, 2019

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 Name: 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 Name: Ambu aura i laryngeal mask airway




Primary Outcome Measures :
  1. airway trauma [ Time Frame: up to 1 minute after extubation ]
    4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062747


Contacts
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Contact: Sinan Yılmaz, Instructor +905324563023 siyilmaz@bezmialem.edu.tr

Locations
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Turkey
Bezmialem Vakıf University Recruiting
Istanbul, Fatih, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04062747    
Other Study ID Numbers: 71306642-S001
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Bezmialem Vakif University:
Laryngeal Mask
I-gel
Ambu Aura i
Flexible bronchoscopy
Laryngopharyngeal damage
Infant
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs