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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03403192
Enrollment
163
Registered
2018-01-18
Start date
2018-01-26
Completion date
2019-10-29
Last updated
2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Injuries

Keywords

EZ Blocker, DLT, Double Lumen Tube, Thoracic Surgery

Brief 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.

Interventions

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.

DEVICEDLT

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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Masking description

The surgeon will be blinded to technique and queried as to the quality of isolation upon entry into the chest and this will be recorded.

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) ReplacementsEnd of surgical procedurePositional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.

Secondary

MeasureTime frameDescription
Time it Takes to Place for Double Lumen Tube (DLT) and EZEnd of surgical procedureTime of placement for both devices
Quality of Lung Isolation Between DevicesEnd of surgical procedureMeasured at 1 hour intervals during operation on a scale of 1-3 with 1 being Excellent, 2 being Fair, and 3 being Poor.
Side Effects of Devices2 days post operationSore throat/hoarseness postoperatively on a scale of 0-100 with 0 being No Sore Throat and 100 being Worst Sore Throat Imaginable.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
41
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. 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.
40
Double Lumen Tube (DLT) in Left Lung
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker. 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.
40
Double Lumen Tube (DLT) in Right Lung
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker. 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.
42
Total163

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyIncomplete3136
Overall StudyLost to Follow-up1200
Overall StudyUnable to respond0100

Baseline characteristics

CharacteristicEZ-Blocker in the Left LungEZ-Blocker in Right LungDouble Lumen Tube (DLT) in Left LungDouble Lumen Tube (DLT) in Right LungTotal
Age, Continuous62.1 years
STANDARD_DEVIATION 10.5
65.3 years
STANDARD_DEVIATION 12.4
66.2 years
STANDARD_DEVIATION 12.9
60.6 years
STANDARD_DEVIATION 11.7
63.5 years
STANDARD_DEVIATION 12.02
Body Mass Index (BMI)27.8 kg/m^2
STANDARD_DEVIATION 4.8
26.5 kg/m^2
STANDARD_DEVIATION 5
28.3 kg/m^2
STANDARD_DEVIATION 4.79
28.5 kg/m^2
STANDARD_DEVIATION 5.6
27.8 kg/m^2
STANDARD_DEVIATION 5.1
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
41 Participants40 Participants40 Participants42 Participants163 Participants
Sex: Female, Male
Female
20 Participants19 Participants15 Participants22 Participants76 Participants
Sex: Female, Male
Male
21 Participants21 Participants25 Participants20 Participants87 Participants
Weight81.0 kilograms
STANDARD_DEVIATION 17.1
77.0 kilograms
STANDARD_DEVIATION 17.7
82.9 kilograms
STANDARD_DEVIATION 16.4
82.0 kilograms
STANDARD_DEVIATION 20
80.7 kilograms
STANDARD_DEVIATION 17.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 400 / 400 / 42
other
Total, other adverse events
0 / 410 / 400 / 400 / 42
serious
Total, serious adverse events
0 / 410 / 400 / 400 / 42

Outcome results

Primary

Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements

Positional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.

Time frame: End of surgical procedure

ArmMeasureValue (NUMBER)
EZ-Blocker in the Left LungNumber of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements13 Number of replacements
EZ-Blocker in Right LungNumber of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements14 Number of replacements
DLT in Left LungNumber of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements14 Number of replacements
DLT in Right LungNumber of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements13 Number of replacements
Secondary

Quality of Lung Isolation Between Devices

Measured at 1 hour intervals during operation on a scale of 1-3 with 1 being Excellent, 2 being Fair, and 3 being Poor.

Time frame: End of surgical procedure

ArmMeasureValue (MEAN)Dispersion
EZ-Blocker in the Left LungQuality of Lung Isolation Between Devices2.76 score on a scaleStandard Deviation 0.39
EZ-Blocker in Right LungQuality of Lung Isolation Between Devices2.70 score on a scaleStandard Deviation 0.48
DLT in Left LungQuality of Lung Isolation Between Devices2.92 score on a scaleStandard Deviation 0.26
DLT in Right LungQuality of Lung Isolation Between Devices2.83 score on a scaleStandard Deviation 0.37
Secondary

Side Effects of Devices

Sore throat/hoarseness postoperatively on a scale of 0-100 with 0 being No Sore Throat and 100 being Worst Sore Throat Imaginable.

Time frame: 2 days post operation

ArmMeasureValue (MEDIAN)
EZ-Blocker in the Left LungSide Effects of Devices0 score on a scale
EZ-Blocker in Right LungSide Effects of Devices3 score on a scale
DLT in Left LungSide Effects of Devices5 score on a scale
DLT in Right LungSide Effects of Devices0 score on a scale
Secondary

Time it Takes to Place for Double Lumen Tube (DLT) and EZ

Time of placement for both devices

Time frame: End of surgical procedure

ArmMeasureValue (MEDIAN)
EZ-Blocker in the Left LungTime it Takes to Place for Double Lumen Tube (DLT) and EZ3.2 Minutes
EZ-Blocker in Right LungTime it Takes to Place for Double Lumen Tube (DLT) and EZ3.3 Minutes
DLT in Left LungTime it Takes to Place for Double Lumen Tube (DLT) and EZ2.0 Minutes
DLT in Right LungTime it Takes to Place for Double Lumen Tube (DLT) and EZ2.6 Minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026