One-lung Ventilation Clinical Trial
Official title:
Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube
Lung isolation is frequently used during thoracic surgery. Two techniques are principally used: the double lumen tube (DLT) and the bronchial blocker (BB). BB is easy to use but its reputation is darken by the need of multiple repositioning during surgery and especially by a slower lung collapse than the DLT. Reading recent literature on the subject and according to the vast experience of numerous hospital centers, it seems that the slowness of lung collapse remains without any solution. This slowness in lung deflation is detrimental to the initiation of video-assisted thoracoscopy surgery (VATS) and could be exacerbated in chronic obstructive disease (COPD) patients. For this reason, BB use is discredited in numerous centers. However, at IUCPQ, the investigators rarely observe slow lung collapse when BB are used. For many years, the investigators have used a systematic denitrogenation of the lung before the initiation of one lung ventilation (OLV). Furthermore, when the patient is positioned in lateral decubitus, the investigators impose an apnea period of about 30 seconds to favor collapse of the isolated lung before inflating the cuff. This apnea is always limited by the occurrence of oxygen desaturation (≤97%). The investigators also proceed to a second period of apnea of 30 seconds associated to a deflated BB's cuff at the pleural opening. Subsequently, the investigators inflate the BB's cuff to obtain definitive lung isolation. The investigators hypothesis is that the use of two apnea periods, when isolating the lung with a BB, will allow the same quality of surgical exposure at 0, 5, 10 and 20 minutes post opening of the pleura, compared to the one obtained with a DLT. The main objective of this study is first to compare the delay between the initiation of OLV and complete lung collapse obtained with BB and DLT, in two groups of patients undergoing VATS. Secondary objectives are: 1) to evaluate the quality of surgical exposure associated to the level of lung collapse, 2) to evaluate the quality of surgical exposure through the video camera, 3) to collect surgeons' opinion regarding the device (BB or DLT) that they thought was used during surgery. After obtaining institutional review board (IRB) approval, the investigators propose a study of 40 patients undergoing an elective VATS at the Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ) involving an one lung ventilation. They will have to be 18 years old or more, to read, understand and sign an informed consent at their pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic surgeons.
Background:
Lung isolation is frequently used during thoracic surgery. Two techniques are principally
used: the double lumen tube (DLT) and the bronchial blocker (BB). Today, the thoracic
surgical technique with more perspective is the video-assisted thoracoscopy surgery (VATS),
which requires an effective lung isolation technique
The DLT is the one that is widely used by the vast majority of anesthesiologists. It has
been introduced in the eighties in its actual version of polyvinyl chloride. Its positioning
with a fibrobronchoscope (FOB) is well established. Its efficiency is reproducible and it is
used without major complication. Its use is limited in the presence of difficult airway.
The BB had appeared in its modern form at the end of the 1990. It is easy to use but its
reputation is darken by the need of multiple repositioning during surgery and especially by
a slower lung collapse than the DLT. The collapse of the isolated lung is the result of
denitrogenation atelectasis and the draining of isolated lung through the inner channel of
the BB. The diameter and the length of the internal channel vary depending of the model. The
BB inner channel is very much smaller (Cook's Arndt: 1.3 mm; Cook's Cohen: 1.6 mm and Fuji's
Uniblocker: 2.0 mm) than the lumen of a DLT, which varies from 6 to 9 mm (for a 35 to a 41
Fr tube).
A comparative study published in 2003 by Campos demonstrated results in favor of the inner
channel draining hypothesis. Authors showed that the lung collapse with the Arndt BB is
longer than with the Uniblocker BB or the BronchoCath DLT and that it needs more suction
through the inner channel (p>0.06). The limitation of this report is that the number of
thoracotomies and of video-assisted thoracoscopies surgery (VATS) was not mentioned.
Furthermore, the side of surgery was not specified. This point is very important since the
inflated cuff of a BB located into the right main bronchus may obstruct the origin the right
upper lobe, and consequently impair its collapse.
In 2009, with a series of 45 thoracotomies and 22 VATS, Narayanaswamy and Slinger
demonstrated that when both lung isolation and one lung ventilation (OLV) are started early,
meaning immediately post-induction and intubation in dorsal decubitus position, and
continuously maintained until the pleural is opened. Similar surgical exposure at 10 and 20
minutes post pleural opening was obtained with all three modern BB as with left DLT. In this
report, the duration of the lung isolation period and of the one lung ventilation was not
specified. We presume that this length was over 20 or 30 minutes before pleural opening,
which created a lung collapse by denitrogenation, as shown by a later publication by the
same research team. An early -20 cmH2O suction (at the start of OLV) through either a DLT or
a Cohen's BB improved lung collapse quality compared to a late application (20 min after
pleural opening). This advantage was not demonstrated with the Arndt BB or the Fuji's.
Another limitation of this study is that it was done with only left unilateral surgeries to
avoid inflating the BB cuff into the right main bronchus. This choice creates an important
selection bias since these results cannot be applied to a universal use of BB.
In 2009, Ko and Slinger also published the following: the use of a fraction of inspired
oxygen (FiO2) of 1.0 (denitrogenation) while ventilating before the initiation of OLV
through a DLT gives a better surgical exposure at 10 and 20 minutes compared to a FiO2 of
0.4. These results are from 4 VATS and 100 thoracotomies.
Early initiation of OLV in dorsal decubitus is not recommended by any author for the
following reasons: an additional OLV period of 15 to 30 minutes is not beneficial for the
patient if desaturation occurs. Moreover, mobilization of patient in lateral decubitus could
lead to complications related to an inflated BB. In fact, proximal movement of the BB's cuff
can completely obstruct the trachea. There is also a risk of trauma to the airway. Note that
these risks are theoretical since they were note described in this context. Since it is
recommended to proceed to lung isolation when the patient in positioned in lateral
decubitus, it is not surprising that these complications are not reported in the literature.
Reading recent literature on the subject and according to the vast experience of numerous
hospital centers, it seems that the slowness of lung collapse remains without any solution.
This slowness in lung deflation is detrimental to the initiation of VATS and could be
exacerbated in COPD patients. For this reason, BB use is discredited in numerous centers.
However, at IUCPQ, the investigators rarely observe slow lung collapse when BB are used. For
many years, the investigators have used a systematic denitrogenation of the lung before the
initiation of OLV. Furthermore, when the patient is positioned in lateral decubitus, the
investigators impose an apnea period of about 30 seconds to favor collapse of the isolated
lung before inflating the cuff. This apnea is always limited by the occurrence of O2
desaturation (≤97%). The investigators also proceed to a second period of apnea of 30
seconds associated to a deflated BB's cuff at the pleural opening. Subsequently, the
investigators inflate the BB's cuff to obtain definitive lung isolation.
Actual literature does not allow the anesthesiologists to conclude clearly on a choice of
bronchial blocker. Thus, the investigators propose a study that will add up to essential
data to make a better choice of lung isolation device.
Hypothesis:
The investigators hypothesis is that the use of two apnea periods, when isolating the lung
with a BB, will allow the same quality of surgical exposure at 0, 5, 10, and 20 minutes post
opening of the pleura compared to the one obtained with DLT. The investigators will use
Fuji's BB and occlude its internal channel to be able to extrapolate the investigators
results with other BB that are actually on the market.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)
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