Evaluation of the EZ Blocker

August 11, 2010 updated by: Medical University of Vienna

Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®

In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.

Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.

The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.

Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • General Hospital of Vienna
        • Contact:
        • Principal Investigator:
          • Kurt Rützler, M.D.
        • Sub-Investigator:
          • Georg Grubhofer, Prof.
        • Sub-Investigator:
          • Helmut Hager, M.D.

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

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery
  • thoracic surgery with requiring single lung ventilation in lateral position
  • ASA Status 1-3
  • Oral and written consent to participation
  • Age 18- 90

Exclusion Criteria:

  • Contraindications against placing a double lume tube, like tracheal lesions, etc.
  • Thoracic surgery within the last four weeks
  • Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
  • BMI higher than 45
  • Patients with a previous diagnoses or suspected difficult airway

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: EZ Blocker
Patients assigned to the EZ group will be intubated using a conventional tube in an adequate size as it is standard of care and single lung ventilation will be provided using the EZ-Blocker.
Procedure: endotracheal intubation
The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.
ACTIVE_COMPARATOR: Double lumen tube
The patients assigned to the "double lume tube" group will be intubated using the double lume tube in an adequate size as it is standard of care.
Procedure: endotracheal intubation
The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from intubation to ventilation:
Time Frame: 5 minutes
is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative sore throat or croakiness
Time Frame: 2 minutes
Documentation of sore throat and croakiness by questioning the patients the day after surgery
2 minutes
resistance to dislocation
Time Frame: 10 minutes
Which device, double-lung-tube or EZ-Blocker, is more resistant to dislocation in endotracheal/endobronchial position, especially when the patient is moved from dorsal to lateral position?
10 minutes
Peripheral oxygen saturation (SpO2)
Time Frame: 3 hours
Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery
3 hours

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

August 1, 2010

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (ESTIMATE)

July 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 096/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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