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

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.

Study Overview

• Status: Unknown
• Conditions: Local Pressure Effects; Simple Ear
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruslan Abdullayev; Phone Number: +905063010833; Email: ruslan_jnr@hotmail.com
• Study Contact Backup: Name: Ülkü Sabuncu; Phone Number: +905337085212; Email: sabuncuulku@gmail.com

Study Locations

• Turkey
  • Adiyaman, Turkey, 02000
    • Recruiting
    • Adiyaman University Research Hospital
    • Contact: Ruslan Abdullayev; Phone Number: +905063010833; Email: ruslan_jnr@hotmail.com
    • Contact: Ülkü Sabuncu; Phone Number: +905337085212; Email: sabuncuulku@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Middle ear pressure changes after the device application (MEP)	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Hemodynamics	Heart rate,arterial blood pressure, haemoglobin saturation rate	Perioperative

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital
• Investigators: Study Director: Ruslan Abdullayev, Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Adiyaman/LMA-MEP