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Lung Collapse With Bronchial Blocker

Isolated Lung Collapse in Two Stages With Bronchial Blocker: Comparison With Double Lumen Tube

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01615263
Enrollment
40
Registered
2012-06-08
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2014-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Blocker, Double Lumen Endotracheal Tube, Lung Isolation Device, One-lung Ventilation, Video-assisted Thoracoscopic Surgery

Keywords

Video-assisted thoracoscopic surgery (VATS), One lung ventilation, Bronchial blocker, Lung collapse, Double lumen tube

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.

Interventions

DEVICELung isolation device

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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Time to Obtain Complete Lung CollapseFrom the beginning of one lung ventilation to 20 minutes after pleural openingFor 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

MeasureTime frameDescription
Quality of Lung CollapseFrom pleural opening to 20 minutes afterAssessment 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 Device20 minutes after pleural opening20 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 CollapseUp to 5 minutes after surgery

Countries

Canada

Participant flow

Recruitment details

From April to October 1st 2012, 111 patients were assessed for inclusion criteria. 71 patients were not included and 40 were enrolled at their pre-operative visit to the thoracic surgery department.

Pre-assignment details

No enrolled patient was excluded from the study prior to the randomization.

Participants by arm

ArmCount
Double Lumen Tube
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
20
Bronchial Blocker
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPost-randomization exclusion02

Baseline characteristics

CharacteristicBronchial BlockerDouble Lumen TubeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants10 Participants17 Participants
Age, Categorical
Between 18 and 65 years
13 Participants10 Participants23 Participants
Age, Continuous61.9 years
STANDARD_DEVIATION 7.5
63.0 years
STANDARD_DEVIATION 18.2
62.4 years
STANDARD_DEVIATION 9.2
Region of Enrollment
Canada
20 participants20 participants40 participants
Sex: Female, Male
Female
10 Participants11 Participants21 Participants
Sex: Female, Male
Male
10 Participants9 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Double Lumen TubeTime to Obtain Complete Lung Collapse47.8 minutesStandard Deviation 35.9
Bronchial BlockerTime to Obtain Complete Lung Collapse32.5 minutesStandard Deviation 11.8
Secondary

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).

Time frame: 20 minutes after pleural opening

ArmMeasureValue (NUMBER)
Double Lumen TubeOpinion on the Device50 percentage of right guess/opinion
Bronchial BlockerOpinion on the Device22.2 percentage of right guess/opinion
Secondary

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

Time frame: From pleural opening to 20 minutes after

ArmMeasureGroupValue (NUMBER)
Double Lumen TubeQuality of Lung CollapseTime 20 min Partial lung collapse not satisfactory5 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 5 min Complete lung collapse20 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 0, Partial lung collapse, satisfactory30 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 10 min, No lung collapse0 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 0, No lung collapse10 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 10 min Partial lung collapse not satisfactory10 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 0, Complete lung collapse15 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 10 min Partial lung collapse, satisfactory60 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 20 min, No lung collapse0 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 10 min Complete lung collapse30 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 5 min, No lung collapse5 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 0, Partial lung collapse, not satisfactory45 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 20 min Partial lung collapse, satisfactory50 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 5 min, Partial lung collapse not satisfactory10 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 20 min Complete lung collapse45 percentage of patients
Double Lumen TubeQuality of Lung CollapseTime 5 min Partial lung collapse, satisfactory65 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 20 min Complete lung collapse78 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 5 min Partial lung collapse, satisfactory39 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 20 min, No lung collapse0 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 0, No lung collapse6 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 0, Partial lung collapse, not satisfactory17 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 0, Partial lung collapse, satisfactory55 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 0, Complete lung collapse22 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 5 min, No lung collapse0 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 5 min, Partial lung collapse not satisfactory6 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 5 min Complete lung collapse55 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 10 min, No lung collapse0 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 10 min Partial lung collapse not satisfactory0 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 10 min Partial lung collapse, satisfactory33 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 10 min Complete lung collapse67 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 20 min Partial lung collapse not satisfactory0 percentage of patients
Bronchial BlockerQuality of Lung CollapseTime 20 min Partial lung collapse, satisfactory22 percentage of patients
Secondary

Use of Suction to Facilitate Lung Collapse

Time frame: Up to 5 minutes after surgery

ArmMeasureValue (NUMBER)
Double Lumen TubeUse of Suction to Facilitate Lung Collapse0 participants
Bronchial BlockerUse of Suction to Facilitate Lung Collapse1 participants

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026