EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery
Condition: Thoracic Injuries
MeSH terms: Thoracic Injuries
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): EZ-Blocker; DLT
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: EZ Blocker; DLT; Double Lumen Tube; Thoracic Surgery