Thoracic Surgery, Lung IsolationNCT02983149
A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation
A study testing Double lumen tube, Fuji blocker and EZ blocker in people with Thoracic Surgery, Lung Isolation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients undergoing thoracic surgery require selective ventilation of one lung, which allows surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Lung Isolation
- What is being tested?
- Double lumen tube, Fuji blocker and EZ blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2015to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age >18 years.
- Thoracic surgery requiring one-lung ventilation for > 30 minutes.
- Able to provide first party consent.
Who cannot join
- Known prior difficult intubation.
- Upper airway exam suggestive of difficult intubation.
- Surgical procedure requiring a right double lumen endotracheal tube (such as left pneumonectomy).
- Evidence on clinically required radiologic imaging of abnormal lower airway anatomy, such as right upper lobe origin of the bronchus.
- Prior thoracic surgery or pleurodesis of the operative side (would delay lung collapse).
- History of severe restrictive lung disease (such as pulmonary fibrosis or emphysema) which may affect inflation/deflation times.
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- Trauma patients requiring video-assisted thoracoscopic surgery
- Has condition(s) that contraindicate a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via a single lumen endotracheal tube.
- Patients with communication difficulties.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, 200 Elizabeth St.
Toronto, Ontario, B3H 1V7
About this study
Patients undergoing thoracic surgery require selective ventilation of one lung, which allows surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are in routine clinical use at University Health Network.
Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design and two balloons, one of which is designed to fall into each of the right and left sides, it may require less repositioning. Initial clinical experience with the EZ Blocker suggests that it may be less likely than other blockers to become malpositioned during surgery.
Read more
This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker at this institution, and to double-lumen tubes, the most commonly used devices to provide lung isolation, with respect to intra-operative malpositioning and the speed of lung separation and efficacy of lung collapse during thoracic surgery.
Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or left-sided DLT, immediately prior to induction of anesthesia.
The primary end points of time to lung isolation and number of required repositioning maneuvers.
Read the detailed description
STUDY END POINTS The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation (inflation of the bronchial cuff or blocker), will be recorded. The thoracic surgeons, using a verbal analogue scale, will assess the lung collapse(lung collapse scores-LCS, 0=no collapse, to 10=complete collapse). The LCS will be assessed and recorded as they open the pleura during the procedure (LCS 0), and at 10 min., (LCS 10), and 20 min. (LCS 20) after opening the pleura. The surgeons will be blinded to the lung isolation device used in the patient. If the lung collapse is not satisfactory, the FOB will be passed to assess the lung isolation, and if necessary reposition the device. A malposition will be defined as a clinically obvious relocation of the devise in the trachea or bronchus and a loss of lung isolation interfering with surgery. The number of repositions of the lung isolation device after initial supine placement, airway pressures, tidal volumes, duration of surgery, and the arterial blood gases 20 minutes after pleural opening will be noted.
In addition to the primary end points of time to lung isolation and number of required repositioning maneuvers, the following variables will be recorded: Age, gender, weight, height, BMI, ASA, airway Mallampati score, pulmonary spirometry (if clinically performed: TLC, FEV1, FVC, DLCO), LCS 0/10/20, ventilatory parameters on OLV (airway pressure, tidal volume, respiratory rate, compliance, duration of OLV and surgery, arterial blood gas 20 minutes after opening the pleura (pH, paO2, pCO2 bicarbonate, base excess, oxygen saturation), and finally the dimensions of the left main bronchus (LMB) and the right main bronchus (RMB) using the on-screen program of the radiology server on the pre-operative chest imaging, by the anesthesiologist.
- Conditions
- Thoracic Surgery, Lung Isolation
- Being tested
- Double lumen tube, Fuji blocker, EZ blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen tubeDevice
Use an double lumen tube to achieve one lung ventilation in thoracic surgeries
Fuji blockerDevice
Use the Fuji blocker to achieve one lung ventilation in thoracic surgeries
EZ blockerDevice
Use the EZ blocker to achieve one lung ventilation in thoracic surgeries
| Study group | Role | What they receive |
|---|---|---|
| Double lumen tube | Other | One lung ventilation will be achieved using a double lumen tube Receives: Device: Double lumen tube |
| Fuji blocker | Other | One lung ventilation will be achieved using the Fuji blocker Receives: Device: Fuji blocker |
| EZ blocker | Other | One lung ventilation will be achieved using the EZ blocker Receives: Device: EZ blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for lung separation
The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation.
Measured: From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)
Number of repositioning maneuvers of the device
The number of repositions of the lung isolation device after initial supine placement
Measured: After initial patient's supine position for the duration of the operation 0-3 hours will be recorded
Lung collapse scores
Time Frame: After opening the pleura, the lung collapse scores will be measured at 0, 10 and 20 minutes (from pleura opening)
Measured: The thoracic surgeons, using a verbal analogue scale, will be assessing the lung collapse score (LCS), from 0=no collapse to 10=complete collapse. LCS will be assessed just after opening the pleura, at 10 min., and 20 min. after opening the pleura.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start10 Dec 2015
- Primary completion31 Jul 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery, Lung IsolationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Peter Slinger, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983149
- Sponsor's protocol ID
- 14-7478-A
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation
- ClinicalTrials.gov ID
- NCT02983149
- Acronym / sponsor ID
- 14-7478-A
- Conditions
- Thoracic Surgery, Lung Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing thoracic surgery require selective ventilation of one lung, which allows surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are in routine clinical use at University Health Network.
Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design and two balloons, one of which is designed to fall into each of the right and left sides, it may require less repositioning. Initial clinical experience with the EZ Blocker suggests that it may be less likely than other blockers to become malpositioned during surgery.
This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker at this institution, and to double-lumen tubes, the most commonly used devices to provide lung isolation, with respect to intra-operative malpositioning and the speed of lung separation and efficacy of lung collapse during thoracic surgery.
Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or left-sided DLT, immediately prior to induction of anesthesia.
The primary end points of time to lung isolation and number of required repositioning maneuvers.
Detailed description
STUDY END POINTS The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation (inflation of the bronchial cuff or blocker), will be recorded. The thoracic surgeons, using a verbal analogue scale, will assess the lung collapse(lung collapse scores-LCS, 0=no collapse, to 10=complete collapse). The LCS will be assessed and recorded as they open the pleura during the procedure (LCS 0), and at 10 min., (LCS 10), and 20 min. (LCS 20) after opening the pleura. The surgeons will be blinded to the lung isolation device used in the patient. If the lung collapse is not satisfactory, the FOB will be passed to assess the lung isolation, and if necessary reposition the device. A malposition will be defined as a clinically obvious relocation of the devise in the trachea or bronchus and a loss of lung isolation interfering with surgery. The number of repositions of the lung isolation device after initial supine placement, airway pressures, tidal volumes, duration of surgery, and the arterial blood gases 20 minutes after pleural opening will be noted.
In addition to the primary end points of time to lung isolation and number of required repositioning maneuvers, the following variables will be recorded: Age, gender, weight, height, BMI, ASA, airway Mallampati score, pulmonary spirometry (if clinically performed: TLC, FEV1, FVC, DLCO), LCS 0/10/20, ventilatory parameters on OLV (airway pressure, tidal volume, respiratory rate, compliance, duration of OLV and surgery, arterial blood gas 20 minutes after opening the pleura (pH, paO2, pCO2 bicarbonate, base excess, oxygen saturation), and finally the dimensions of the left main bronchus (LMB) and the right main bronchus (RMB) using the on-screen program of the radiology server on the pre-operative chest imaging, by the anesthesiologist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double lumen tube | Other | Device: Double lumen tubeOne lung ventilation will be achieved using a double lumen tube |
| Fuji blocker | Other | Device: Fuji blockerOne lung ventilation will be achieved using the Fuji blocker |
| EZ blocker | Other | Device: EZ blockerOne lung ventilation will be achieved using the EZ blocker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years.
- Thoracic surgery requiring one-lung ventilation for > 30 minutes.
- Able to provide first party consent.
Key exclusion criteria (9 listed)
- Known prior difficult intubation.
- Upper airway exam suggestive of difficult intubation.
- Surgical procedure requiring a right double lumen endotracheal tube (such as left pneumonectomy).
- Evidence on clinically required radiologic imaging of abnormal lower airway anatomy, such as right upper lobe origin of the bronchus.
- Prior thoracic surgery or pleurodesis of the operative side (would delay lung collapse).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double lumen tubeUse an double lumen tube to achieve one lung ventilation in thoracic surgeries | Device | Double lumen tube |
| Fuji blockerUse the Fuji blocker to achieve one lung ventilation in thoracic surgeries | Device | Fuji blocker |
| EZ blockerUse the EZ blocker to achieve one lung ventilation in thoracic surgeries | Device | EZ blocker |
Primary outcome
Time required for lung separation
Time frame: From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)
The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation.
Number of repositioning maneuvers of the device
Time frame: After initial patient's supine position for the duration of the operation 0-3 hours will be recorded
The number of repositions of the lung isolation device after initial supine placement
Lung collapse scores
Time frame: The thoracic surgeons, using a verbal analogue scale, will be assessing the lung collapse score (LCS), from 0=no collapse to 10=complete collapse. LCS will be assessed just after opening the pleura, at 10 min., and 20 min. after opening the pleura.
Time Frame: After opening the pleura, the lung collapse scores will be measured at 0, 10 and 20 minutes (from pleura opening)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Efficacy and Safety of the Visual Bronchial Blocker for Lung Isolation Surgery
Thoracic Surgery With One-lung Ventilation, Lung Isolation
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During Chest Surgery, One Lung is Isolated From Ventilation to Improve Visibility, With Carbon Dioxide Introduced Between the Lung and Chest Wall (Capnothorax): the Study Seeks to Optimize Ventilation Through Esophageal Pressure Measurement, Reducing Respiratory Complications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Slinger, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double lumen tube, Fuji blocker and EZ blocker in people with Thoracic Surgery, Lung Isolation, run by University Health Network, Toronto 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 9 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 4 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 required for lung separation (time frame: From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2021.