The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients
NCT ID: NCT02334072
Last Updated: 2015-06-23
Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Classical
Laryngeal mask airway (LMA) is manufactured from medical grade silicone rubber and is reusable. It consists of 3 main components: An airway tube, inflatable mask and mask inflation line. The airway tube is slightly curved to match the oropharyngeal anatomy, semirigid to facilitate atraumatic insertion and semitransparent, so that condensation and regurgitated material is visible. The distal aperture of the airway tube opens into the lumen of an inflatable mask and is protected by two flexible vertical rubber bars, called mask aperture bars, to prevent the epiglottis from entering and obstructing the airway. The laryngeal mask classical application will be done following anesthesia induction.
Laryngeal mask classical application
Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device.
I-Gel
I-Gel LMA is anatomically designed mask made of a gel-like thermoplastic elastomer. It has a drain tube for gastric aspiration. I-gel laryngeal mask application will be done following anesthesia induction.
I-gel laryngeal mask application
I-gel laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Cobra
Cobra LMA consists of a translucent silicone airway tube with an inflatable cuff sited approximately two-thirds of the way to the tip, a 15-mm standard adapter and an expanded distal end with a smooth posterior surface. The cuff forms a seal in the upper pharynx and the distal end sits in the laryngopharynx. The distal grill is designed to sit over the laryngeal inlet.Cobra laryngeal mask application will be done following induction of anesthesia
Cobra laryngeal mask application
Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Supreme
The Supreme LMA is a single-use polyvinyl chloride supraglottic device. High oropharyngeal leak pressures are important as they indicate airway protection, feasibility of positive pressure ventilation and likelihood of successful LMA placement.Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia.
Supreme laryngeal mask application
Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Proseal
The ProSeal LMA is the most complex of the specialized laryngeal mask devices.The primary design goal was to construct a laryngeal mask with improved ventilatory characteristics that also offered protection against regurgitation and gastric insufflation. The principal new features are a modified cuff and a drain tube.Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia.
Proseal laryngeal mask application
Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Interventions
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Laryngeal mask classical application
Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device.
I-gel laryngeal mask application
I-gel laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Cobra laryngeal mask application
Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Supreme laryngeal mask application
Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Proseal laryngeal mask application
Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Rejection of patient approval
* Tympanic membrane perforation history
* Anticipated difficult airway
* Contraindications for LMA application
1 Day
18 Years
ALL
No
Sponsors
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Adiyaman University Research Hospital
OTHER
Responsible Party
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Dr. Ülkü Sabuncu
Dr
Principal Investigators
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Ruslan Abdullayev
Role: STUDY_DIRECTOR
Adiyaman University Research Hospital
Locations
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Adiyaman University Research Hospital
Adıyaman, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Adiyaman/LMA-MEP
Identifier Type: -
Identifier Source: org_study_id
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