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The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Dr. Ülkü Sabuncu, Adiyaman University Research Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02334072
First Posted: January 8, 2015
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ülkü Sabuncu, Adiyaman University Research Hospital
  Purpose
Even though the effects of anesthetic agents both inhalation and intravenous have been well described, the effect of laryngeal mask airways haven't. The purpose of the study is to determine the effects of different types of laryngeal mask airways on middle ear pressure.

Condition Intervention
Local Pressure Effects Simple Ear Device: Laryngeal mask classical application Device: I-gel laryngeal mask application Device: Cobra laryngeal mask application Device: Supreme laryngeal mask application Device: Proseal laryngeal mask application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients

Further study details as provided by Dr. Ülkü Sabuncu, Adiyaman University Research Hospital:

Primary Outcome Measures:
  • Middle ear pressure changes after the device application (MEP) [ Time Frame: Perioperative ]

Secondary Outcome Measures:
  • Composite Hemodynamics [ Time Frame: Perioperative ]
    Heart rate,arterial blood pressure, haemoglobin saturation rate


Estimated Enrollment: 100
Study Start Date: January 2015
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Laryngeal mask classical application
Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Experimental: 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.
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.
Experimental: 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
Device: Cobra laryngeal mask application
Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Experimental: 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.
Device: Supreme laryngeal mask application
Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
Experimental: 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.
Device: Proseal laryngeal mask application
Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.

Detailed Description:
All the patients in each group of laryngeal mask airway will contain 20 patients. In all groups middle ear pressures will be measured, in both right and left ear, preoperatively, after induction of anesthesia, insertion of laryngeal mask and in 1st., 5th., 10th. minutes and every 5 minutes perioperatively and recorded. Also the heart rates,arterial oxygen saturation (SaO2), airway pressures and end-tidal carbon dioxide values will be recorded before and following induction of anesthesia and in 1st., 5th., 10th. minutes and every five minutes perioperatively. Patients will be followed during the hospital stay for any complications.In all groups premedication will be done with midazolam. Anesthesia will be inducted with propofol and fentanyl; and maintained with sevoflurane-air combination.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT02334072


Contacts
Contact: Ülkü Sabuncu +905337085212 sabuncuulku@gmail.com
Contact: Ruslan Abdullayev +905063010833 ruslan_jnr@hotmail.com

Locations
Turkey
Adiyaman University Research Hospital Recruiting
Adiyaman, Turkey, 02000
Contact: Ülkü Sabuncu    +905337085212    sabuncuulku@gmail.com   
Contact: Ruslan Abdullayev    +905063010833    ruslan_jnr@hotmail.com   
Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
Study Director: Ruslan Abdullayev Adiyaman University Research Hospital
  More Information

Responsible Party: Dr. Ülkü Sabuncu, Dr, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT02334072     History of Changes
Other Study ID Numbers: Adiyaman/LMA-MEP
First Submitted: January 5, 2015
First Posted: January 8, 2015
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs