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

NCT02334072 | Unknown

• 1 other identifier: Adiyaman/LMA-MEP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Local Pressure Effects; Simple Ear

Outcome Measures

Primary Outcomes (1)

• Middle ear pressure changes after the device application (MEP)

  Perioperative

Secondary Outcomes (1)

• Composite Hemodynamics

  Perioperative

Study Arms (5)

Classical

EXPERIMENTAL

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

I-Gel

EXPERIMENTAL

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

Cobra

EXPERIMENTAL

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

Supreme

EXPERIMENTAL

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

Proseal

EXPERIMENTAL

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

Interventions

Laryngeal mask classical application DEVICE

Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device.

Classical

I-gel laryngeal mask application DEVICE

I-gel laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.

I-Gel

Cobra laryngeal mask application DEVICE

Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.

Cobra

Supreme laryngeal mask application DEVICE

Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.

Supreme

Proseal laryngeal mask application DEVICE

Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.

Proseal

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Elective patients undergoing subumbilical surgery under general anesthesia

You may not qualify if:

• Emergency conditions
• Rejection of patient approval
• Tympanic membrane perforation history
• Anticipated difficult airway
• Contraindications for LMA application

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, 02000, Turkey (Türkiye)

RECRUITING

Study Officials

• Ruslan Abdullayev

  Adiyaman University Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Ülkü Sabuncu

CONTACT

+905337085212; sabuncuulku@gmail.com

Ruslan Abdullayev

CONTACT

+905063010833; ruslan_jnr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

TU (1)