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

June 22, 2015 updated by: Dr. Ülkü Sabuncu, Adiyaman University Research Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Adiyaman, Turkey, 02000
        • Recruiting
        • Adiyaman University Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Middle ear pressure changes after the device application (MEP)
Time Frame: Perioperative
Perioperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite Hemodynamics
Time Frame: Perioperative
Heart rate,arterial blood pressure, haemoglobin saturation rate
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adiyaman University Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ruslan Abdullayev, Adiyaman University Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Adiyaman/LMA-MEP

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