EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/22/2019 |
| Start Date: | January 26, 2018 |
| End Date: | June 2019 |
| Contact: | Benjamin N Morris, MD |
| Email: | bmorris@wakehealth.edu |
| Phone: | 336-716-2602 |
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 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.
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 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.
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.
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.
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
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