Lung Collapse With Bronchial Blocker

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean Bussières, Laval University
ClinicalTrials.gov Identifier:
NCT01615263
First received: May 25, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Video-assisted Thoracoscopic Surgery
Lung Isolation Device
One-lung Ventilation
Double Lumen Endotracheal Tube
Bronchial Blocker
Device: Lung isolation device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Time to Obtain Complete Lung Collapse [ Time Frame: From the beginning of one lung ventilation to 20 minutes after pleural opening ] [ Designated as safety issue: No ]
    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:
  • Quality of Lung Collapse [ Time Frame: From pleural opening to 20 minutes after ] [ Designated as safety issue: No ]

    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

  • Opinion on the Device [ Time Frame: 20 minutes after pleural opening ] [ Designated as safety issue: No ]
    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).

  • Use of Suction to Facilitate Lung Collapse [ Time Frame: Up to 5 minutes after surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01615263

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

Additional Information:
Publications:
Responsible Party: Jean Bussières, Anesthesiologist, Full clinical professor, Laval University
ClinicalTrials.gov Identifier: NCT01615263     History of Changes
Other Study ID Numbers: IUCPQ 20784
Study First Received: May 25, 2012
Results First Received: May 23, 2013
Last Updated: February 27, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014