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

NCT ID: NCT02334072

Last Updated: 2015-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Local Pressure Effects Simple Ear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Laryngeal mask classical application

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

I-gel laryngeal mask application

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Cobra laryngeal mask application

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Supreme laryngeal mask application

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Proseal laryngeal mask application

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laryngeal mask classical application

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

Intervention Type 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.

Intervention Type DEVICE

Cobra laryngeal mask application

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

Intervention Type DEVICE

Supreme laryngeal mask application

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

Intervention Type DEVICE

Proseal laryngeal mask application

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adiyaman University Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Ülkü Sabuncu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruslan Abdullayev

Role: STUDY_DIRECTOR

Adiyaman University Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adiyaman University Research Hospital

Adıyaman, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ülkü Sabuncu

Role: CONTACT

+905337085212

Ruslan Abdullayev

Role: CONTACT

+905063010833

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ülkü Sabuncu

Role: primary

+905337085212

Ruslan Abdullayev

Role: backup

+905063010833

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Adiyaman/LMA-MEP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.