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

Local Pressure Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334072
• Other study ID #: Adiyaman/LMA-MEP
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2015
• Last updated: June 22, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Adiyaman University Research Hospital
• Contact: Ülkü Sabuncu
• Phone: +905337085212
• Email: sabuncuulku[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Local Pressure Effects
• Simple Ear

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle ear pressure changes after the device application (MEP)		Perioperative	Yes
Secondary	Composite Hemodynamics	Heart rate,arterial blood pressure, haemoglobin saturation rate	Perioperative	Yes