Clinical trial NCT01615263: Lung Collapse With Bronchial Blocker
Official title: Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracoscopic Surgery
Lung Isolation Device
One-lung Ventilation
Double Lumen Endotracheal Tube
Bronchial Blocker
Keywords: Video-assisted thoracoscopic surgery (VATS)
One lung ventilation
Bronchial blocker
Lung collapse
Double lumen tube
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* elective video-assisted thoracoscopy
* one lung ventilation

Exclusion Criteria:

* Difficult mask ventilation
* planned difficult intubation
* use of a right double lumen tube
* severe COPD (VEMS \< 50% and Tiffeneau \< 50% of the predicted values)
* asthma (instable \<1 year)
* bulla disease
* pleural disease
* previous ipsilateral thoracic surgery
* thoracic radiotherapy
* significant systemic co-morbidity
* active or chronic pulmonary infection
* fibrosis, other interstitial diseases
* endobronchial mass
* right upper lobe bronchus at the pericarinal level (preoperative or at the first FOB under anesthesia)

Primary outcomes:
measure: Time to Obtain Complete Lung Collapse
timeFrame: From the beginning of one lung ventilation to 20 minutes after pleural opening
Secondary outcomes:
measure: Quality of Lung Collapse
timeFrame: From pleural opening to 20 minutes after
measure: Opinion on the Device
timeFrame: 20 minutes after pleural opening
measure: Use of Suction to Facilitate Lung Collapse
timeFrame: Up to 5 minutes after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Laval University
name: Jean S Bussières, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campos JH, Kernstine KH. A comparison of a left-sided Broncho-Cath with the torque control blocker univent and the wire-guided blocker. Anesth Analg. 2003 Jan;96(1):283-9, table of contents. doi: 10.1097/00000539-200301000-00056.
citation: Ko R, McRae K, Darling G, Waddell TK, McGlade D, Cheung K, Katz J, Slinger P. The use of air in the inspired gas mixture during two-lung ventilation delays lung collapse during one-lung ventilation. Anesth Analg. 2009 Apr;108(4):1092-6. doi: 10.1213/ane.0b013e318195415f.
citation: Narayanaswamy M, McRae K, Slinger P, Dugas G, Kanellakos GW, Roscoe A, Lacroix M. Choosing a lung isolation device for thoracic surgery: a randomized trial of three bronchial blockers versus double-lumen tubes. Anesth Analg. 2009 Apr;108(4):1097-101. doi: 10.1213/ane.0b013e3181999339.
citation: Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
citation: Fortier G, Cote D, Bergeron C, Bussieres JS. New landmarks improve the positioning of the left Broncho-Cath double-lumen tube-comparison with the classic technique. Can J Anaesth. 2001 Sep;48(8):790-4. doi: 10.1007/BF03016696.
citation: Bussieres JS, Somma J, Del Castillo JL, Lemieux J, Conti M, Ugalde PA, Gagne N, Lacasse Y. Bronchial blocker versus left double-lumen endotracheal tube in video-assisted thoracoscopic surgery: a randomized-controlled trial examining time and quality of lung deflation. Can J Anaesth. 2016 Jul;63(7):818-27. doi: 10.1007/s12630-016-0657-3. Epub 2016 May 2.