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Video-assisted Thoracoscopic SurgeryNCT01615263

Lung Collapse With Bronchial Blocker

A study testing Lung isolation device in people with Video-assisted Thoracoscopic Surgery and Lung Isolation Device, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lung isolation device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
Apr 2012to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Lung isolation device
Keywords
Video-assisted thoracoscopic surgery (VATS), One lung ventilation, Bronchial blocker, Lung collapse, Double lumen tube
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung isolation deviceDevice

    Also called BronchoCath, Mallinckrodt Medical

    Lung isolation for one-lung ventilation with a left double lumen tube

  • Lung isolation deviceDevice

    Also called Fuji Uniblocker 9 French

    Lung isolation for one-lung ventilation with a bronchial blocker inserted through a 8.0 mm simple lumen endotracheal tube

Study groups in NCT01615263
Study groupRoleWhat they receive
Double lumen tubeActive comparatorLung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.
Receives: Device: Lung isolation device
Bronchial blockerActive comparatorLung 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.
Receives: Device: Lung isolation device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the beginning of one lung ventilation to 20 minutes after pleural opening

Secondary outcomes (3)
  1. Quality of Lung Collapse

    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

    Measured: From pleural opening to 20 minutes after

  2. Opinion on the Device

    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).

    Measured: 20 minutes after pleural opening

  3. Use of Suction to Facilitate Lung Collapse

    Measured: Up to 5 minutes after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionOct 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01615263
Sponsor's protocol ID
IUCPQ 20784
Status last verified
Feb 2014
First submitted
25 May 2012
Last updated
27 Mar 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 12505967
  • 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.

    PubMed 19299766
  • 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.

    PubMed 19299767
  • Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.

    PubMed 20007992
  • 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.

    PubMed 11546721
  • 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.

    PubMed 27138896

Questions about this trial

What is this clinical trial studying?

A study testing Lung isolation device in people with Video-assisted Thoracoscopic Surgery and Lung Isolation Device, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Obtain Complete Lung Collapse (time frame: From the beginning of one lung ventilation to 20 minutes after pleural opening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01615263, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.

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