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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 August 2015
Main ID:  NCT02334072
Date of registration: 05/01/2015
Prospective Registration: No
Primary sponsor: Adiyaman University Research Hospital
Public title: The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients
Scientific title: The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients
Date of first enrolment: January 2015
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02334072
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Turkey
Contacts
Name:     Ülkü Sabuncu
Address: 
Telephone: +905337085212
Email: sabuncuulku@gmail.com
Affiliation: 
Name:     Ruslan Abdullayev
Address: 
Telephone:
Email:
Affiliation:  Adiyaman University Research Hospital
Name:     Ülkü Sabuncu
Address: 
Telephone: +905337085212
Email: sabuncuulku@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Elective patients undergoing subumbilical surgery under general anesthesia

Exclusion Criteria:

- Emergency conditions

- Rejection of patient approval

- Tympanic membrane perforation history

- Anticipated difficult airway

- Contraindications for LMA application



Age minimum: N/A
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Local Pressure Effects
Simple Ear
Intervention(s)
Device: Cobra laryngeal mask application
Device: I-gel laryngeal mask application
Device: Proseal laryngeal mask application
Device: Laryngeal mask classical application
Device: Supreme laryngeal mask application
Primary Outcome(s)
Middle ear pressure changes after the device application (MEP) [Time Frame: Perioperative]
Secondary Outcome(s)
Composite Hemodynamics [Time Frame: Perioperative]
Secondary ID(s)
Adiyaman/LMA-MEP
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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