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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02334072
Enrollment
100
Registered
2015-01-08
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Pressure Effects, Simple Ear

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.

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.

Interventions

DEVICELaryngeal mask classical application

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

DEVICEI-gel laryngeal mask application

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

DEVICECobra laryngeal mask application

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

DEVICESupreme laryngeal mask application

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

DEVICEProseal laryngeal mask application

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

Sponsors

Adiyaman University Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Middle ear pressure changes after the device application (MEP)Perioperative

Secondary

MeasureTime frameDescription
Composite HemodynamicsPerioperativeHeart rate,arterial blood pressure, haemoglobin saturation rate

Countries

Turkey (Türkiye)

Contacts

Primary ContactÜlkü Sabuncu
sabuncuulku@gmail.com+905337085212
Backup ContactRuslan Abdullayev
ruslan_jnr@hotmail.com+905063010833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026