EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery

September 9, 2021 updated by: Wake Forest University Health Sciences

A Comparison of Positional Stability: the EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery

The objective of this study is to evaluate the positional stability and quality of lung isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic surgery.

An additional objective will be to assess time to placement of both devices and other significant clinical differences between these two approaches to placement of the bronchial blocker (BB) including airway injury and post-operatives sore throat, post-operative hoarseness, Additionally we would like to examine the preoperative high resolution CT imaging data to determine if there are anatomic landmarks that may potentially inform the appropriateness or inappropriateness of choosing an EZ-blocker or left sided DLT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One lung ventilation (OLV) is frequently used in thoracic surgery to promote surgical exposure and improve operative conditions. At this time, there are two different approaches to OLV in routine use in adult thoracic surgery. One approach is to use of a double lumen tube (DLT). The other approach is to use a bronchial blocker (BB). Currently there are several different types of bronchial BBs on the market.

The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other.

A number of studies have been performed comparing BBs to DLTs looking at time and ease of placement, differences in quality of lung isolation, and incidence of sore throat, hoarseness, and other morbidity associated with placement. A recent meta-analysis published by Clayton-Smith et al found that BBs are associated with fewer airway injuries when compared to DLTs. They found the quality of isolation to be equivalent between BBs and DLTs. While quality of isolation over all may be comparable, it has been demonstrated in several studies that positional stability of bronchial blockers such as the Arndt or Cohen, is frequently inferior to that of a DLT.

At this time, there are a small number of trials looking at the use of the EZ-blocker in adult patients. In one study published in 2013 the EZ-blocker was compared to the Cohen Flex-Tip blocker. In this study they found that time to place the EZ-blocker was in fact shorter and that overall the number of repositioning required was less with the EZ-blocker. In 2013, a study was published by Mourisse et al which compared DLT to the EZ-blocker. In this study they found initial malposition of both devices to be fairly equivalent, and time to placement was longer with the EZ-blocker. They also found more tracheal and bronchial injuries in the DLT group, but importantly they found that positional stability was equivalent. In both of these studies however they did not design their studies to effectively differentiate between right and left sided procedures when quantifying the need for BB repositioning. Because the takeoff of the right upper lobe bronchus is sometimes adjacent to, or proximal to the carina, it can impede effective isolation with a BB. Therefore, claims of positional stability may rely heavily on the laterality of the procedure, with right sided isolation being significantly more labile than left sided especially with respect to isolation using a BB.

According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through alongside the EZ-blocker to visualize and confirm placement of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.

In conclusion then, the study team feels that the potential morbidity of a DLT in terms of the potential for airway injury when compared to a BB suggests that further exploration of the possibility of equivalent positional stability between these devices is necessary. The team also feels that it is necessary to delineate the impact of laterality on the effectiveness of one technique for isolation versus the other.

In addition to this if there is a difference in stability in cases where right sided isolation via the EZ-blocker fails in the setting of multiple repositions or out and out failure the team would like to examine the preoperative high resolution CT data to determine if there are anatomic measurement which could potentially inform the appropriateness or inappropriateness of choosing a DLT over an EZ-blocker.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • 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 Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients greater than 18 and 80 years of age scheduled for thoracoscopic surgery or thoracotomy requiring lung isolation
  • Patient presenting as an outpatient for elective thoracic surgery
  • In patients scheduled for thoracic surgery.

Exclusion Criteria:

  • History of difficult airway/intubation
  • Patients suspected to have a difficult airway.
  • Morbid obesity BMI >39
  • Pregnancy
  • Emergency status of surgery
  • Thoracic surgery requiring a right sided double lumen tube

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EZ-Blocker in the left lung
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
Device: EZ-Blocker
The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
Active Comparator: EZ-Blocker in right lung
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
Device: EZ-Blocker
The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
Active Comparator: DLT in left lung
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
Device: DLT
A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
Active Comparator: DLT in right lung
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
Device: DLT
A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements
Time Frame: End of surgical procedure
Positional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.
End of surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time it Takes to Place for Double Lumen Tube (DLT) and EZ
Time Frame: End of surgical procedure
Time of placement for both devices
End of surgical procedure
Quality of Lung Isolation Between Devices
Time Frame: End of surgical procedure
Measured at 1 hour intervals during operation on a scale of 1-3 with 1 being Excellent, 2 being Fair, and 3 being Poor.
End of surgical procedure
Side Effects of Devices
Time Frame: 2 days post operation
Sore throat/hoarseness postoperatively on a scale of 0-100 with 0 being No Sore Throat and 100 being Worst Sore Throat Imaginable.
2 days post operation

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Benjamin N Morris, MD, Assistant Professor

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 (Actual)

January 26, 2018

Primary Completion (Actual)

October 29, 2019

Study Completion (Actual)

October 29, 2019

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00038220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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