An interventional study of I-gel and Ambu aura i in Mucosal Damage, sponsored by Bezmialem Vakif University. Status unknown at 1 site in Turkey. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Screening
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.
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.
Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After standard anesthesia i-Gel was placed into the patient.
Device: I-gel
After standard anesthesia Ambu Aura-i was placed into the patient.
Device: Ambu aura i
After standard anesthesia i-Gel was placed into the patient
Also known as: I-gel laryngeal mask airway
After standard anesthesia ambu aura was placed into the patient
Also known as: Ambu aura i laryngeal mask airway
airway trauma
4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding
Time frame: up to 1 minute after extubation
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Bezmialem Vakif University