Lung Collapse With Bronchial Blocker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615263
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : September 19, 2013
Last Update Posted : March 27, 2014
Information provided by (Responsible Party):
Jean Bussières, Laval University

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.

Condition or disease Intervention/treatment Phase
Video-assisted Thoracoscopic Surgery Lung Isolation Device One-lung Ventilation Double Lumen Endotracheal Tube Bronchial Blocker Device: Lung isolation device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Double lumen tube
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.
Device: Lung isolation device
Lung isolation for one-lung ventilation with a left double lumen tube
Other Name: BronchoCath, Mallinckrodt Medical
Active Comparator: Bronchial blocker
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.
Device: Lung isolation device
Lung isolation for one-lung ventilation with a bronchial blocker inserted through a 8.0 mm simple lumen endotracheal tube
Other Name: Fuji Uniblocker 9 French

Primary Outcome Measures :
  1. Time to Obtain Complete Lung Collapse [ Time Frame: From the beginning of one lung ventilation to 20 minutes after pleural opening ]
    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.

Secondary Outcome Measures :
  1. Quality of Lung Collapse [ Time Frame: From pleural opening to 20 minutes after ]

    Assessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following:

    1. No lung collapse
    2. Partial lung collapse, not satisfactory
    3. Partial lung collapse, satisfactory
    4. Complete lung collapse

  2. Opinion on the Device [ Time Frame: 20 minutes after pleural opening ]
    20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).

  3. Use of Suction to Facilitate Lung Collapse [ Time Frame: Up to 5 minutes after surgery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615263

Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Principal Investigator: Jean S Bussières, MD Laval University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean Bussières, Anesthesiologist, Full clinical professor, Laval University Identifier: NCT01615263     History of Changes
Other Study ID Numbers: IUCPQ 20784
First Posted: June 8, 2012    Key Record Dates
Results First Posted: September 19, 2013
Last Update Posted: March 27, 2014
Last Verified: February 2014

Keywords provided by Jean Bussières, Laval University:
Video-assisted thoracoscopic surgery (VATS)
One lung ventilation
Bronchial blocker
Lung collapse
Double lumen tube

Additional relevant MeSH terms:
Pulmonary Atelectasis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases