One-lung VentilationC-TDLNCT03508050
Clamping the Double Lumen Tube
A study testing Clamping the Double Lumen Tube in people with One-lung Ventilation, run by Jean Bussières at 1 site in Canada.
Trial summary
Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-lung Ventilation
- What is being tested?
- Clamping the Double Lumen Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 29 Sep 2017to 12 Jan 2018
- 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
- Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV.
- More than 18 years old.
- Having read, understand and signed the consent form presented at the pre-operative evaluation
Who cannot join
- A- Pre-operative
- Known or anticipated difficult tracheal intubation.
- Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
- Severe COPD or asthma (FEV1 <50%).
- Prior intrathoracic surgery (including cardiac surgeries).
- Pleural or interstitial pathology.
Show all 15Show fewer
- Previous chemotherapy or thoracic radiotherapy.
- Acute or chronic pulmonary infection.
- Endobronchial mass.
- Tracheostomy.
- B- Post-randomisation
- Bronchoscopic findings contraindicating the insertion of DLT.
- VATS findings that cancel the surgery.
- Severe desaturation (SatO2 < 90%) during the observation period.
- Any need to reinflate the collapse lung.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation
Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it.
The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air.
Read more
The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.
This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).
Read the detailed description
One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated.
Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening.
A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas.
Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group.
Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded.
The hypothesis is that by withholding gas exchange between the NVL and ambient air from the beginning of OLV to the pleural opening, the resorption atelectasis will be facilitated. Consequently, lung collapse of the NVL will occur faster when clamping its specific lumen on the DLT instead of letting it communicate with ambient air like anesthesiologists usually do.
- Conditions
- One-lung Ventilation
- Being tested
- Clamping the Double Lumen Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamping the Double Lumen TubeDevice
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Clamping double lumen tube | Experimental | Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation Receives: Device: Clamping the Double Lumen Tube |
| Not Clamping double lumen tube | No intervention | Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
T50-3
Moment where the probability of having a complete lung collapse is 50%
Measured: From the beginning of surgery (pleural opening) until 120 minutes
Secondary outcomes (12)
Complete Lung Collapse (CLC-clinical)
The time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery
Measured: From the beginning of surgery (pleural opening) until 60 minutes
O2 Concentration of Expired Air at Pleural Opening
A measure of the O2 concentration of the expiratory air at pleural opening
Measured: From pleural opening and lasting 60 seconds
Expiratory Volume at Pleural Opening
A measure of the expiratory volume (EV) at pleural opening
Measured: From pleural opening and lasting 60 seconds
O2 Concentration of Expired Air at the Beginning of One-lung Ventilation
A measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)
Measured: From the beginning of one-lung ventilation and lasting 60 seconds
Optimization of Lung Collapse
Number of Participants needing Other Interventions to Optimize Lung Collapse
Measured: From the beginning of surgery (pleural opening) until 60 minutes
Quality of Oxygenation During One-lung Ventilation (PaO2 )
An evaluation of the PaO2 during one-lung ventilation
Measured: 25 minutes after pleural opening
Quality of Oxygenation During One-lung Ventilation (SaO2)
An evaluation of the SaO2during one-lung ventilation
Measured: 25 minutes after pleural opening
Surgery Duration
Time required for completion of the surgery
Measured: From the beginning of surgery (pleural opening) until 120 minutes
Postoperative Atelectasis
Number of atelectasis detected by Postoperative X-Ray
Measured: End of hospitalization
Quality of Lung Collapse (Clinical) at 0 Minute
A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Measured: At pleural opening (0 minute)
Quality of Lung Collapse (Clinical) at 10 Minutes
A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Measured: 10 minutes after pleural opening
Quality of Lung Collapse (Clinical) at 20 Minutes
A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome
Measured: 20 minutes after pleural opening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start29 Sep 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
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 (8)Papers the sponsor has linked to this study.
- Other trials for One-lung VentilationStudies of the same condition, open and under way.
- 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
- Model description
- Just before induction of anesthesia and according to the computerized randomization list generated by the statistical department, each of the 30 patients is allocated to one of the following groups: Control group : OLV with the specific lumen of the NVL opened to ambient air. Experimental group : OLV with a clamp on the specific lumen of the NVL
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Bussières
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Bussières, Laval University
- Investigators
- Sabrina Pelletier, MD, Principal investigator, Laval UniversityJean S Bussières, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508050
- Sponsor's protocol ID
- 21436
- Acronym
- C-TDL
- Status last verified
- Apr 2020
- First submitted
- 27 Sep 2017
- Last updated
- 27 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clayton-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 25753765Campos 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 8942598Bussieres 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 27138896Pfitzner 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 10995140Joyce 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 8482648Bardoczky GI, Engelman E, d'Hollander A. Continuous spirometry: an aid to monitoring ventilation during operation. Br J Anaesth. 1993 Nov;71(5):747-51. doi: 10.1093/bja/71.5.747.
PubMed 8251293Bussieres JS, Slinger P. Correct positioning of double-lumen tubes. Can J Anaesth. 2012 May;59(5):431-6. doi: 10.1007/s12630-012-9689-5. Epub 2012 Mar 7. No abstract available. English, French.
PubMed 22395826Somma J, Couture EJ, Pelletier S, Provencher S, Moreault O, Lohser J, Ugalde PA, Vigneault L, Lemieux J, Somma A, Guay SE, Bussieres JS. Non-ventilated lung deflation during one-lung ventilation with a double-lumen endotracheal tube: a randomized-controlled trial of occluding the non-ventilated endobronchial lumen before pleural opening. Can J Anaesth. 2021 Jun;68(6):801-811. doi: 10.1007/s12630-021-01957-9. Epub 2021 Apr 2.
PubMed 33797018
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation
- ClinicalTrials.gov ID
- NCT03508050
- Acronym / sponsor ID
- C-TDL / 21436
- Conditions
- One-lung Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Jean BussièresUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it.
The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air.
The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.
This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).
Detailed description
One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated.
Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening.
A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas.
Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group.
Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded.
The hypothesis is that by withholding gas exchange between the NVL and ambient air from the beginning of OLV to the pleural opening, the resorption atelectasis will be facilitated. Consequently, lung collapse of the NVL will occur faster when clamping its specific lumen on the DLT instead of letting it communicate with ambient air like anesthesiologists usually do.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Just before induction of anesthesia and according to the computerized randomization list generated by the statistical department, each of the 30 patients is allocated to one of the following groups: Control group : OLV with the specific lumen of the NVL opened to ambient air. Experimental group : OLV with a clamp on the specific lumen of the NVL
| Arm | Type | Receives |
|---|---|---|
| Clamping double lumen tube | Experimental | Device: Clamping the Double Lumen TubeClamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation |
| Not Clamping double lumen tube | No intervention | –Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV.
- More than 18 years old.
- Having read, understand and signed the consent form presented at the pre-operative evaluation
Key exclusion criteria (15 listed)
- A- Pre-operative
- Known or anticipated difficult tracheal intubation.
- Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
- Severe COPD or asthma (FEV1 <50%).
- Prior intrathoracic surgery (including cardiac surgeries).
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 |
|---|---|---|
| Clamping the Double Lumen TubeClamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation | Device | Clamping double lumen tube |
Primary outcome
T50-3
Time frame: From the beginning of surgery (pleural opening) until 120 minutes
Moment where the probability of having a complete lung collapse is 50%
12 secondary outcomes
Complete Lung Collapse (CLC-clinical)
Time frame: From the beginning of surgery (pleural opening) until 60 minutes
O2 Concentration of Expired Air at Pleural Opening
Time frame: From pleural opening and lasting 60 seconds
Expiratory Volume at Pleural Opening
Time frame: From pleural opening and lasting 60 seconds
O2 Concentration of Expired Air at the Beginning of One-lung Ventilation
Time frame: From the beginning of one-lung ventilation and lasting 60 seconds
Optimization of Lung Collapse
Time frame: From the beginning of surgery (pleural opening) until 60 minutes
Quality of Oxygenation During One-lung Ventilation (PaO2 )
Time frame: 25 minutes after pleural opening
Quality of Oxygenation During One-lung Ventilation (SaO2)
Time frame: 25 minutes after pleural opening
Surgery Duration
Time frame: From the beginning of surgery (pleural opening) until 120 minutes
Postoperative Atelectasis
Time frame: End of hospitalization
Quality of Lung Collapse (Clinical) at 0 Minute
Time frame: At pleural opening (0 minute)
Quality of Lung Collapse (Clinical) at 10 Minutes
Time frame: 10 minutes after pleural opening
Quality of Lung Collapse (Clinical) at 20 Minutes
Time frame: 20 minutes after pleural opening
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 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 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 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 8251293Bardoczky GI, Engelman E, d'Hollander A. Continuous spirometry: an aid to monitoring ventilation during operation. Br J Anaesth. 1993 Nov;71(5):747-51. doi: 10.1093/bja/71.5.747.
- Background: PubMed 22395826Bussieres JS, Slinger P. Correct positioning of double-lumen tubes. Can J Anaesth. 2012 May;59(5):431-6. doi: 10.1007/s12630-012-9689-5. Epub 2012 Mar 7. No abstract available. English, French.
- Derived from this study: PubMed 33797018Somma J, Couture EJ, Pelletier S, Provencher S, Moreault O, Lohser J, Ugalde PA, Vigneault L, Lemieux J, Somma A, Guay SE, Bussieres JS. Non-ventilated lung deflation during one-lung ventilation with a double-lumen endotracheal tube: a randomized-controlled trial of occluding the non-ventilated endobronchial lumen before pleural opening. Can J Anaesth. 2021 Jun;68(6):801-811. doi: 10.1007/s12630-021-01957-9. Epub 2021 Apr 2.
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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.
Sabrina Pelletier, 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 Clamping the Double Lumen Tube in people with One-lung Ventilation, run by Jean Bussières 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 15 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 Apr 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 27 Apr 2020). 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?
T50-3 (time frame: From the beginning of surgery (pleural opening) until 120 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 NCT03508050, which also lists 8 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 Apr 2020.