Lung CollapsePLC-OLVNCT02919267
Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
A study testing Double lumen tube and Bronchial blocker in people with Lung Collapse and One-Lung Ventilation, run by Laval University at 1 site in Canada.
Trial summary
Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV is not well described in the literature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Collapse, One-Lung Ventilation, Thoracic Surgery
- What is being tested?
- Double lumen tube and Bronchial blocker
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective unilateral lung resection (anatomical segmentectomy, lobectomy or pneumonectomy) for lung cancer
Who cannot join
- anticipated difficult mask ventilation or intubation
- pleural pathology
- previous thoracic surgery
- previous sternotomy
- previous chemotherapy or chest radiotherapy
- severe COPD or asthma (FEV1 ≤ 50%)
Show all 13Show fewer
- active or chronic pulmonary infection
- endobronchial mass
- tracheostomy
- Post randomisation exclusion criteria :
- severe desaturation before or during the observation period
- any clinical situation precluding the use of one of the lung isolation device
- air leak at the level of bronchial isolation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec
About this study
Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV is not well described in the literature. Few publications characterized scant aspects of lung collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung collapse have been described. The first phase is a quick and partial secondary to the intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the alveoli by the capillary bed. The investigators plan to describe the physiology of the second phase of lung deflation using of DLT or BB, in a human clinical context.
Read the detailed description
Lung isolation and one-lung ventilation (OLV) have been used for more than 60 years, principally via double lumen endotracheal tubes (DLT). Since the beginning of the 21st century, modernisation of bronchial blockers (BB) has favoured their more frequent use. Meanwhile, video assisted thoracoscopic surgery (VATS) has increased, becoming the standard for the majority of intra-thoracic pulmonary surgeries.
Lung collapse during OLV undergoes two distinct phases. The first phase occurs at the opening of the pleural cavity and corresponds to a quick but partial collapse of the lung due to its intrinsic recoil. This phase probably ends when small airways are closed. Thereafter, the second phase, a slower one, corresponds to the reabsorption, by the capillary bed, of gas contained into the alveoli. The speed of this reabsorption depends on the solubility of the gas contained in the alveoli.
Intriguingly, the physiology of lung collapse under OLV remains poorly understood, especially with the use of BB. Theoretically, many aspects of lung isolation may influence lung collapse, including the ventilation strategy before OLV, the timing and the lung isolation devices being used. While oxygen at 100% is widely used for ventilation before OLV, the timing of initiation of lung isolation varies from centers to centers. Indeed, the most conservative will begin the lung isolation just before the opening of the pleural space, whereas others begin the lung isolation following the appropriate positioning of the patient and confirmation that the lung isolation device is properly positioned by fiberoptic bronchoscopy (FOB) examination. Therefore, the period between initiation of lung isolation and pleural opening may vary from a few minutes to >30 minutes. The mechanic of lung isolation differs between DLT and BB and consequently the physiology of lung deflation may be different. When using DLT, the lumen that corresponds to the collapsed lung is disconnected from the ventilator and is continuously in communication with the ambient air. When using BB a bronchial cuff is inflated within the main bronchus following a 30 seconds apnea period, allowing the initial lung deflation to be mediated by elastic lung recoil. After this initial phase, the only communication with ambient air is through the small (2 mm) and long internal (67 mm) channel, which is completely different from the larger lumen of the DLT.
Rapid and complete lung collapse is essential during lung isolation for VATS otherwise; there is no alternative available for the surgeon to get proper view of the pulmonary hilum. Previous studies suggested that BB allow a less effective lung collapse than the one obtained with DLT. However, the authors recently documented that the use of BB with its internal channel occluded creates a statistically significant shorter time to complete lung collapse during VATS compared to DLT (36.6 ± 29.1 vs 7.5 ± 3.8 min; p<0.001). In contrast to the previous studies, the authors used off-line review videos recorded during the surgery to obtain a more objective evaluation of the complete lung collapse time which probably reflected the second phase of lung deflation. Although, our definition of lung collapse was very strict, meaning complete collapse of all the lung areas, graded using a standardized visual scale and chart. However, authors do not have any data to explain why this internal channel occlusion may have some positive impact. The authors hypothesized that their results could be explained by the optimisation of the reabsorption phases following enhanced atelectasis by gas reabsorption (phase 2) after bronchial blockade. This latter hypothesis is supported by a pilot observation that ambient air (FiO2 at 0.21) was "sucked up" within the collapsing lung when using DLT to a greater extent than with the use of BB (unpublished data). The presence of ambient air (21%) in the alveolar space may likely slowing subsequent gas reabsorption compared to intra-alveolar 100% O2 . However, these hypotheses remain to be confirmed.
The investigators proposed this study to update the knowledge about lung collapse with the actual lung isolation devices: DLT and BB. This protocol will describe the lung collapse physiology and allows getting data for the elaboration of further studies.
Thus the present hypothesis is that during the second phase of lung collapse, the inflow of air through the lumen of the non-ventilated lung of the DLT is greater than through the internal channel of the BB, in the course of lung isolation for OLV.
The main objective of this study is the gas volume quantification (GVQ) coming from ambient air towards the alveoli space of the non-ventilated lung during OLV with the use of DLT and BB. These measurements will be performed from the beginning of OLV until 60 minutes after, meaning approximatively 45 minutes after the opening of the pleura by the surgeon. The secondary objective is the intra-pulmonary pressure measurement (IPM) in the non-ventilated lung with the use of DLT and BB during the same period.
- Conditions
- Lung Collapse, One-Lung Ventilation, Thoracic Surgery, Video-Assisted
- Being tested
- Double lumen tube, Bronchial blocker
- Keywords
- One lung ventilation, Lung collapse, Bronchial blocker, Double lumen tube, video assisted thoracoscopic surgery, VATS, DLT, Thoracic surgery, Video-assisted
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen tubeDevice
Also called Left-sided double lumen tube (BronchoCath, Mallinkrodt)
Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group.
Bronchial blockerDevice
Also called Bronchial blocker (Fuji Uniblocker, Fuji Systems)
Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group.
| Study group | Role | What they receive |
|---|---|---|
| Intra-pulmonary pressure determination | Other | A pressure tubing catheter will be connected to the luerlock adaptor of the bronchial blocker (BB) or to the adaptor located on the side of the occluding system mounted at the extremity of the double lumen tube (DLT). The catheter will then be connected to a differential pressure transducer (AD Instruments, Colorado Springs, CO, USA), allowing direct visualisation of the bronchial pressures. Along with intra-bronchial pressure, esophageal pressure will also be measured to eliminate the pressure generated by the positive pressure of the ventilated lung (Adult esophageal balloon catheter, Cooper Surgical, Trumbull, CT, USA). Intra-bronchial pressures will be measured at end-inspiration and end-expiration. Receives: Device: Double lumen tube; Device: Bronchial blocker |
| Volume determination | Other | A one-liter bag (Roxon, Etobicoke, ON, Canada) will be filled precisely with 300 mL of air with the use of a calibrated syringe of 3 liters (Hans Rudolph inc, Shawnee, Kansas, United States), through a three-way valve (Hans Rudolph inc, Shawnee, Kansas, United States). Following the filling of the bag, it will be connected to the non-ventilated lumen of the double lumen tube (DLT) or to the bronchial blocker (BB) through the three-way connector. At the end of the observation period, the collector bag will be connected to the calibrated syringe and will emptied from its residual volume. Receives: Device: Double lumen tube; Device: Bronchial blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.
Measured: From the beginning of OLV until 60 minutes
Secondary outcomes (1)
Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB
Intra-pulmonary pressure measured from initiation of OLV to pleural opening were similarly analyzed using a two-way ANOVA. Two experimental factors, one associated to the comparison between two groups (DLT versus BB), factor fixed and one associated to the comparison among results from the time periods (0 to 10 minutes), factor fixed with interaction terms between the fixed factors were defined. The data was analyzed using a repeated mixed model. An autoregressive covariance structure was used to consider the dependency among repeated measurements.
Measured: From the beginning until 10 minutes of OLV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Lung CollapseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Bussières, Laval University
- Investigators
- Olivier Moreault, MD, Principal investigator, Laval UniversityJean S Bussières, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919267
- Sponsor's protocol ID
- IUCPQ 21299
- Acronym
- PLC-OLV
- Status last verified
- May 2020
- First submitted
- 28 Sep 2016
- Last updated
- 26 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shah RD, D'Amico TA. Modern impact of video assisted thoracic surgery. J Thorac Dis. 2014 Oct;6(Suppl 6):S631-6. doi: 10.3978/j.issn.2072-1439.2014.08.02.
PubMed 25379201Joyce CJ, Baker AB, Kennedy RR. Gas uptake from an unventilated area of lung: computer model of absorption atelectasis. J Appl Physiol (1985). 1993 Mar;74(3):1107-16. doi: 10.1152/jappl.1993.74.3.1107.
PubMed 8482648Pfitzner J, Peacock MJ, McAleer PT. Gas movement in the nonventilated lung at the onset of single-lung ventilation for video-assisted thoracoscopy. Anaesthesia. 1999 May;54(5):437-43. doi: 10.1046/j.1365-2044.1999.00845.x.
PubMed 10995140Pfitzner J, Peacock MJ, Harris RJ. Speed of collapse of the non-ventilated lung during single-lung ventilation for thoracoscopic surgery: the effect of transient increases in pleural pressure on the venting of gas from the non-ventilated lung. Anaesthesia. 2001 Oct;56(10):940-6. doi: 10.1046/j.1365-2044.2001.02211.x.
PubMed 11576095Campos JH, Reasoner DK, Moyers JR. Comparison of a modified double-lumen endotracheal tube with a single-lumen tube with enclosed bronchial blocker. Anesth Analg. 1996 Dec;83(6):1268-72. doi: 10.1097/00000539-199612000-00024.
PubMed 8942598Bauer C, Winter C, Hentz JG, Ducrocq X, Steib A, Dupeyron JP. Bronchial blocker compared to double-lumen tube for one-lung ventilation during thoracoscopy. Acta Anaesthesiol Scand. 2001 Feb;45(2):250-4.
PubMed 11167173Campos 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 12505967Dumans-Nizard V, Liu N, Laloe PA, Fischler M. A comparison of the deflecting-tip bronchial blocker with a wire-guided blocker or left-sided double-lumen tube. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):501-5. doi: 10.1053/j.jvca.2009.02.002. Epub 2009 Apr 10.
PubMed 19362014Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2.
PubMed 25753765Bussieres 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 27138896Merchant R, Chartrand D, Dain S, Dobson J, Kurrek M, LeDez K, Morgan P, Shukla R; Canadian Anesthesiologists' Society. Guidelines to the Practice of Anesthesia Revised Edition 2012. Can J Anaesth. 2012 Jan;59(1):63-102. doi: 10.1007/s12630-011-9609-0. English, French.
PubMed 22183296Brodsky JB, Lemmens HJ. Tracheal width and left double-lumen tube size: a formula to estimate left-bronchial width. J Clin Anesth. 2005 Jun;17(4):267-70. doi: 10.1016/j.jclinane.2004.07.008.
PubMed 15950850Fortier 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 11546721Kovacs G, Avian A, Olschewski A, Olschewski H. Zero reference level for right heart catheterisation. Eur Respir J. 2013 Dec;42(6):1586-94. doi: 10.1183/09031936.00050713. Epub 2013 Jun 21.
PubMed 23794468Joyce CJ, Baker AB, Parkinson R, Zacharias M. Nitrous oxide and the rate of gas uptake from an unventilated lung in dogs. Br J Anaesth. 1996 Feb;76(2):292-6. doi: 10.1093/bja/76.2.292.
PubMed 8777113
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT02919267
- Acronym / sponsor ID
- PLC-OLV / IUCPQ 21299
- Conditions
- Lung Collapse, One-Lung Ventilation, Thoracic Surgery, Video-Assisted
- Keywords
- One lung ventilation, Lung collapse, Bronchial blocker, Double lumen tube, video assisted thoracoscopic surgery, VATS, DLT, Thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV is not well described in the literature. Few publications characterized scant aspects of lung collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung collapse have been described. The first phase is a quick and partial secondary to the intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the alveoli by the capillary bed. The investigators plan to describe the physiology of the second phase of lung deflation using of DLT or BB, in a human clinical context.
Detailed description
Lung isolation and one-lung ventilation (OLV) have been used for more than 60 years, principally via double lumen endotracheal tubes (DLT). Since the beginning of the 21st century, modernisation of bronchial blockers (BB) has favoured their more frequent use. Meanwhile, video assisted thoracoscopic surgery (VATS) has increased, becoming the standard for the majority of intra-thoracic pulmonary surgeries.
Lung collapse during OLV undergoes two distinct phases. The first phase occurs at the opening of the pleural cavity and corresponds to a quick but partial collapse of the lung due to its intrinsic recoil. This phase probably ends when small airways are closed. Thereafter, the second phase, a slower one, corresponds to the reabsorption, by the capillary bed, of gas contained into the alveoli. The speed of this reabsorption depends on the solubility of the gas contained in the alveoli.
Intriguingly, the physiology of lung collapse under OLV remains poorly understood, especially with the use of BB. Theoretically, many aspects of lung isolation may influence lung collapse, including the ventilation strategy before OLV, the timing and the lung isolation devices being used. While oxygen at 100% is widely used for ventilation before OLV, the timing of initiation of lung isolation varies from centers to centers. Indeed, the most conservative will begin the lung isolation just before the opening of the pleural space, whereas others begin the lung isolation following the appropriate positioning of the patient and confirmation that the lung isolation device is properly positioned by fiberoptic bronchoscopy (FOB) examination. Therefore, the period between initiation of lung isolation and pleural opening may vary from a few minutes to >30 minutes. The mechanic of lung isolation differs between DLT and BB and consequently the physiology of lung deflation may be different. When using DLT, the lumen that corresponds to the collapsed lung is disconnected from the ventilator and is continuously in communication with the ambient air. When using BB a bronchial cuff is inflated within the main bronchus following a 30 seconds apnea period, allowing the initial lung deflation to be mediated by elastic lung recoil. After this initial phase, the only communication with ambient air is through the small (2 mm) and long internal (67 mm) channel, which is completely different from the larger lumen of the DLT.
Rapid and complete lung collapse is essential during lung isolation for VATS otherwise; there is no alternative available for the surgeon to get proper view of the pulmonary hilum. Previous studies suggested that BB allow a less effective lung collapse than the one obtained with DLT. However, the authors recently documented that the use of BB with its internal channel occluded creates a statistically significant shorter time to complete lung collapse during VATS compared to DLT (36.6 ± 29.1 vs 7.5 ± 3.8 min; p<0.001). In contrast to the previous studies, the authors used off-line review videos recorded during the surgery to obtain a more objective evaluation of the complete lung collapse time which probably reflected the second phase of lung deflation. Although, our definition of lung collapse was very strict, meaning complete collapse of all the lung areas, graded using a standardized visual scale and chart. However, authors do not have any data to explain why this internal channel occlusion may have some positive impact. The authors hypothesized that their results could be explained by the optimisation of the reabsorption phases following enhanced atelectasis by gas reabsorption (phase 2) after bronchial blockade. This latter hypothesis is supported by a pilot observation that ambient air (FiO2 at 0.21) was "sucked up" within the collapsing lung when using DLT to a greater extent than with the use of BB (unpublished data). The presence of ambient air (21%) in the alveolar space may likely slowing subsequent gas reabsorption compared to intra-alveolar 100% O2 . However, these hypotheses remain to be confirmed.
The investigators proposed this study to update the knowledge about lung collapse with the actual lung isolation devices: DLT and BB. This protocol will describe the lung collapse physiology and allows getting data for the elaboration of further studies.
Thus the present hypothesis is that during the second phase of lung collapse, the inflow of air through the lumen of the non-ventilated lung of the DLT is greater than through the internal channel of the BB, in the course of lung isolation for OLV.
The main objective of this study is the gas volume quantification (GVQ) coming from ambient air towards the alveoli space of the non-ventilated lung during OLV with the use of DLT and BB. These measurements will be performed from the beginning of OLV until 60 minutes after, meaning approximatively 45 minutes after the opening of the pleura by the surgeon. The secondary objective is the intra-pulmonary pressure measurement (IPM) in the non-ventilated lung with the use of DLT and BB during the same period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-pulmonary pressure determination | Other | Device: Double lumen tube, Device: Bronchial blockerA pressure tubing catheter will be connected to the luerlock adaptor of the bronchial blocker (BB) or to the adaptor located on the side of the occluding system mounted at the extremity of the double lumen tube (DLT). The catheter will then be connected to a differential pressure transducer (AD Instruments, Colorado Springs, CO, USA), allowing direct visualisation of the bronchial pressures. Along with intra-bronchial pressure, esophageal pressure will also be measured to eliminate the pressure generated by the positive pressure of the ventilated lung (Adult esophageal balloon catheter, Cooper Surgical, Trumbull, CT, USA). Intra-bronchial pressures will be measured at end-inspiration and end-expiration. |
| Volume determination | Other | Device: Double lumen tube, Device: Bronchial blockerA one-liter bag (Roxon, Etobicoke, ON, Canada) will be filled precisely with 300 mL of air with the use of a calibrated syringe of 3 liters (Hans Rudolph inc, Shawnee, Kansas, United States), through a three-way valve (Hans Rudolph inc, Shawnee, Kansas, United States). Following the filling of the bag, it will be connected to the non-ventilated lumen of the double lumen tube (DLT) or to the bronchial blocker (BB) through the three-way connector. At the end of the observation period, the collector bag will be connected to the calibrated syringe and will emptied from its residual volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective unilateral lung resection (anatomical segmentectomy, lobectomy or pneumonectomy) for lung cancer
Key exclusion criteria (13 listed)
- anticipated difficult mask ventilation or intubation
- pleural pathology
- previous thoracic surgery
- previous sternotomy
- previous chemotherapy or chest radiotherapy
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 tubeAlso: Left-sided double lumen tube (BronchoCath, Mallinkrodt)Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group. | Device | Intra-pulmonary pressure determination, Volume determination |
| Bronchial blockerAlso: Bronchial blocker (Fuji Uniblocker, Fuji Systems)Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group. | Device | Intra-pulmonary pressure determination, Volume determination |
Primary outcome
Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.
Time frame: From the beginning of OLV until 60 minutes
1 secondary outcome
Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB
Time frame: From the beginning until 10 minutes of OLV
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25379201Shah RD, D'Amico TA. Modern impact of video assisted thoracic surgery. J Thorac Dis. 2014 Oct;6(Suppl 6):S631-6. doi: 10.3978/j.issn.2072-1439.2014.08.02.
- Background: PubMed 8482648Joyce CJ, Baker AB, Kennedy RR. Gas uptake from an unventilated area of lung: computer model of absorption atelectasis. J Appl Physiol (1985). 1993 Mar;74(3):1107-16. doi: 10.1152/jappl.1993.74.3.1107.
- Background: PubMed 10995140Pfitzner J, Peacock MJ, McAleer PT. Gas movement in the nonventilated lung at the onset of single-lung ventilation for video-assisted thoracoscopy. Anaesthesia. 1999 May;54(5):437-43. doi: 10.1046/j.1365-2044.1999.00845.x.
- Background: PubMed 11576095Pfitzner J, Peacock MJ, Harris RJ. Speed of collapse of the non-ventilated lung during single-lung ventilation for thoracoscopic surgery: the effect of transient increases in pleural pressure on the venting of gas from the non-ventilated lung. Anaesthesia. 2001 Oct;56(10):940-6. doi: 10.1046/j.1365-2044.2001.02211.x.
- Background: PubMed 8942598Campos JH, Reasoner DK, Moyers JR. Comparison of a modified double-lumen endotracheal tube with a single-lumen tube with enclosed bronchial blocker. Anesth Analg. 1996 Dec;83(6):1268-72. doi: 10.1097/00000539-199612000-00024.
- Background: PubMed 11167173Bauer C, Winter C, Hentz JG, Ducrocq X, Steib A, Dupeyron JP. Bronchial blocker compared to double-lumen tube for one-lung ventilation during thoracoscopy. Acta Anaesthesiol Scand. 2001 Feb;45(2):250-4.
- Background: PubMed 12505967Campos 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.
- Background: PubMed 19362014Dumans-Nizard V, Liu N, Laloe PA, Fischler M. A comparison of the deflecting-tip bronchial blocker with a wire-guided blocker or left-sided double-lumen tube. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):501-5. doi: 10.1053/j.jvca.2009.02.002. Epub 2009 Apr 10.
- Background: PubMed 25753765Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2.
- Background: PubMed 27138896Bussieres 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.
- Background: PubMed 22183296Merchant R, Chartrand D, Dain S, Dobson J, Kurrek M, LeDez K, Morgan P, Shukla R; Canadian Anesthesiologists' Society. Guidelines to the Practice of Anesthesia Revised Edition 2012. Can J Anaesth. 2012 Jan;59(1):63-102. doi: 10.1007/s12630-011-9609-0. English, French.
- Background: PubMed 15950850Brodsky JB, Lemmens HJ. Tracheal width and left double-lumen tube size: a formula to estimate left-bronchial width. J Clin Anesth. 2005 Jun;17(4):267-70. doi: 10.1016/j.jclinane.2004.07.008.
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Septic Shock
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.
Olivier Moreault, MD principal investigator
Laval University
Jean S Bussières, MD principal investigator
Laval University
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 and Bronchial blocker in people with Lung Collapse and One-Lung Ventilation, 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 1 inclusion and 13 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 26 May 2020. 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 22 Jul 2019). 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?
Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB. (time frame: From the beginning of OLV until 60 minutes). 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 NCT02919267, which also lists 19 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 26 May 2020.