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Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube
Sponsor study identifier
interventional
40
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 25, 2012
Actual (reported)June 8, 2012
Actual (reported)October 2012
Actual (reported)December 2012
Actual (reported)September 19, 2013
Actual (reported)Time to Obtain Complete Lung Collapse
For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.
From the beginning of one lung ventilation to 20 minutes after pleural opening
Quality of Lung Collapse
From pleural opening to 20 minutes after
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
Lung isolation for one-lung ventilation with a left double lumen tube
Lung isolation for one-lung ventilation with a bronchial blocker inserted through a 8.0 mm simple lumen endotracheal tube
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
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.
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.
Jean S Bussières, MD
Laval University
40 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2012
First Posted
June 8, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Opinion on the Device
20 minutes after pleural opening
Use of Suction to Facilitate Lung Collapse
Up to 5 minutes after surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
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.
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.
Primary Completion
October 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
March 27, 2014
Results First Posted
September 19, 2013
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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