Video-assisted Thoracoscopic Surgery (VATS)IPg2NCT02137291
IPg2 Study: Left-sided Lung Isolation
An observational study of Video-assisted Thoracoscopic Surgery (VATS) and One-lung Ventilation, run by Laval University at 1 site in Canada.
Trial summary
Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the majority of anesthesiologists for both left and right thoracic surgeries. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery (VATS), One-lung Ventilation
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Nov 2015
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing an elective left VATS requiring OLV
Who may be able to join
- signed informed consent
- elective left video-assisted thoracoscopy
- one lung ventilation
Who cannot join
- Anticipated difficult mask ventilation or intubation
- tracheal or high bronchial origin of the right upper lobe main bronchus
- severe COPD or asthma
- pleural disease
- previous left thoracic surgery
- chest radiotherapy
Show all 14Show fewer
- chimiotherapy
- significant systemic co-morbidity
- active or chronic pulmonary infection
- fibrosis, other interstitial diseases
- endobronchial mass
- tracheostomy
- severe desaturation in the peroperative period
- any clinical situation precluding the use of an isolation device
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
About this study
Official title: IPg2 Study - Left-sided Lung Isolation: Comparison of Twodevices
Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the majority of anesthesiologists for both left and right thoracic surgeries. Standard right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and that there is a risk of misalignment between the lateral orifice of the tube and the origin of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend to provide quicker and better quality of lung collapse than BB. In 2013, investigators have demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two apnea periods when initiating OLV. Complementary analysis showed a significative difference to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to compare the delay between pleural opening (PO) and CLC in left VATS when using three lung isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used and 5) to measure the delay between OLV and PO for evaluating the role of absorption atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They will have to be 21 years or more, to read, understand and sign an informed consent at their pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic surgeons.
Read the detailed description
Background:
Lung isolation is frequently used in thoracic surgery. The quality of the isolation is crucial, especially for video-assisted thoracoscopic surgery (VATS). Two techniques are principally used to obtain lung isolation: the double lumen tube (DLT) and the bronchial blocker (BB).
The left-sided DLT (L-DLT) is used by the majority of anesthesiologists, as much for left as for right thoracic surgeries. The standard right-sided DLT (Rs-DLT) is rarely used since positioning its lateral orifice with the origin of the right upper lobe (RUL) can be difficult.(1-4) In 2007, the investigators have published their results suggesting an enlargement of the lateral orifice of the Rs-DLT.(5) They have demonstrated that the modified right-sided double lumen tube (Rm-DLT) remained more frequently in optimal position than the Rs-DLT (77% vs. 37%, p=0.0121) and that it was also easier to reposition the tube after turning the patient in lateral decubitus (97% vs. 74%, p=0.0109).
More recently, investigators have demonstrated, with three dimensional reconstruction of computed tomography of 106 patients, that angulation between the RUL and the horizontal posterior plane varies from -26 to +58°, justifying the modification of the Rs-DLT proposed in 2007. (Unpublished data)
The use of BB for lung isolation is believed to provide a slower and a poorer quality of lung collapse (LC) than DLT. Over the years, the investigators have demonstrated an equivalent quality of lung collapse between the L-DLT and BB when two apnea periods are used at the beginning of one-lung ventilation (OLV). (Unpublished data) Further to complementary analysis, investigators have noted a significant difference in time to get complete lung collapse between left and right thoracic surgery when using the L-DLT. Time to obtain complete lung collapse (CLC) was not different when comparing BB and L-DLT in left thoracic surgery.
The hypothesis to explain these observations is that when the bronchial extremity of the L-DLT is inserted into the left main stem bronchus (LMSB), the LMSB and its relative superior position, associated to a progressive collapse of the left lung, could induce a dynamic obstruction of the distal extremity of the L-DLT lumen, and consequently slowing the lung collapse. Investigators have also regularly observed this type of obstruction during bronchoscopic examination when positioning the L-DLT.
In past studies comparing L-DLT to BB, time to get CLC was measured from the beginning of OLV. Nevertheless, the interval between this time point and the pleural opening (PO) is sometime difficult to control. Technical incidents can prolong this period and induce a bias. Furthermore, in the last investigator's protocol, the second period of apnea is done at pleural opening. For these reasons, the authors consider that the time to get CLC should be measured from the pleural opening since it is the crucial moment for the surgical team. Investigators are proposing to evaluate the PO-CLC interval as a primary objective.(6)
Hypothesis:
The hypothesis of the proposed study is that the use of the L-DLT will allow for a slower and a poorer quality of CLC compared to the ones obtained with the Rm-DLT in left VATS.
- Keywords
- Video-assisted thoracoscopic surgery (VATS), Lung isolation device, One-lung ventilation, Double lumen endotracheal tube, Bronchial blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left-sided double-lumen tube | Lung isolation with a left-sided double-lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland) | |
| Modified right-sided double-lumen tube | Right-sided double-lumen tube modified in accordance with Bussières et al. in Can J Anesth 2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtain complete lung collapse
Time to obtain complete lung collapse will be collected from the pleural opening up to complete lung collapse.
Measured: Peroperative
Secondary outcomes (5)
Quality of lung collapse
Quality of lung collapse from de beginning of one-lung ventilation to the end of surgery
Measured: Peroperative
Degree of obstruction of the right upper lobe bronchus lumen
Degree of obstruction of the right upper lobe bronchus lumen from de beginning of one-lung ventilation to the end of surgery
Measured: Peroperative
Quality of one-lung ventilation
Quality of one-lung ventilation from de beginning of one-lung ventilation to the end of surgery
Measured: Peroperative
Thoracic surgeon's guess about the device used
Thoracic surgeon must guess which device was used by the anesthesiologist to isolate the lung 20 minutes after pleural opening. Choice: 1= L-DLT or 2= Rm-DLT
Measured: Peroperative
Time between the beginning of one-lung ventilation to pleural opening
Time between the beginning of one-lung ventilation to pleural opening from de beginning of one-lung ventilation to the pleural opening
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Video-assisted Thoracoscopic Surgery (VATS)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- 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
- Jean S Bussières, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137291
- Sponsor's protocol ID
- IUCPQ-20952
- Acronym
- IPg2
- Status last verified
- Oct 2017
- First submitted
- 19 Sep 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Slinger P. The clinical use of right-sided double-lumen tubes. Can J Anaesth. 2010 Apr;57(4):293-300. doi: 10.1007/s12630-009-9262-z. No abstract available. English, French.
PubMed 20058114McKenna MJ, Wilson RS, Botelho RJ. Right upper lobe obstruction with right-sided double-lumen endobronchial tubes: a comparison of two tube types. J Cardiothorac Anesth. 1988 Dec;2(6):734-40. doi: 10.1016/0888-6296(88)90096-8.
PubMed 17171882Bussieres JS, Lacasse Y, Cote D, Beauvais M, St-Onge S, Lemieux J, Soucy J. Modified right-sided Broncho-Cath double lumen tube improves endobronchial positioning: a randomized study. Can J Anaesth. 2007 Apr;54(4):276-82. doi: 10.1007/BF03022772.
PubMed 17400979Ko R, McRae K, Darling G, Waddell TK, McGlade D, Cheung K, Katz J, Slinger P. The use of air in the inspired gas mixture during two-lung ventilation delays lung collapse during one-lung ventilation. Anesth Analg. 2009 Apr;108(4):1092-6. doi: 10.1213/ane.0b013e318195415f.
PubMed 19299766Brodsky 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 11546721
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPg2 Study - Left-sided Lung Isolation: Comparison of Twodevices
- ClinicalTrials.gov ID
- NCT02137291
- Acronym / sponsor ID
- IPg2 / IUCPQ-20952
- Keywords
- Video-assisted thoracoscopic surgery (VATS), Lung isolation device, One-lung ventilation, Double lumen endotracheal tube, Bronchial blocker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 May 2014 (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.
Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the majority of anesthesiologists for both left and right thoracic surgeries. Standard right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and that there is a risk of misalignment between the lateral orifice of the tube and the origin of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend to provide quicker and better quality of lung collapse than BB. In 2013, investigators have demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two apnea periods when initiating OLV. Complementary analysis showed a significative difference to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to compare the delay between pleural opening (PO) and CLC in left VATS when using three lung isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used and 5) to measure the delay between OLV and PO for evaluating the role of absorption atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They will have to be 21 years 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 in thoracic surgery. The quality of the isolation is crucial, especially for video-assisted thoracoscopic surgery (VATS). Two techniques are principally used to obtain lung isolation: the double lumen tube (DLT) and the bronchial blocker (BB).
The left-sided DLT (L-DLT) is used by the majority of anesthesiologists, as much for left as for right thoracic surgeries. The standard right-sided DLT (Rs-DLT) is rarely used since positioning its lateral orifice with the origin of the right upper lobe (RUL) can be difficult.(1-4) In 2007, the investigators have published their results suggesting an enlargement of the lateral orifice of the Rs-DLT.(5) They have demonstrated that the modified right-sided double lumen tube (Rm-DLT) remained more frequently in optimal position than the Rs-DLT (77% vs. 37%, p=0.0121) and that it was also easier to reposition the tube after turning the patient in lateral decubitus (97% vs. 74%, p=0.0109).
More recently, investigators have demonstrated, with three dimensional reconstruction of computed tomography of 106 patients, that angulation between the RUL and the horizontal posterior plane varies from -26 to +58°, justifying the modification of the Rs-DLT proposed in 2007. (Unpublished data)
The use of BB for lung isolation is believed to provide a slower and a poorer quality of lung collapse (LC) than DLT. Over the years, the investigators have demonstrated an equivalent quality of lung collapse between the L-DLT and BB when two apnea periods are used at the beginning of one-lung ventilation (OLV). (Unpublished data) Further to complementary analysis, investigators have noted a significant difference in time to get complete lung collapse between left and right thoracic surgery when using the L-DLT. Time to obtain complete lung collapse (CLC) was not different when comparing BB and L-DLT in left thoracic surgery.
The hypothesis to explain these observations is that when the bronchial extremity of the L-DLT is inserted into the left main stem bronchus (LMSB), the LMSB and its relative superior position, associated to a progressive collapse of the left lung, could induce a dynamic obstruction of the distal extremity of the L-DLT lumen, and consequently slowing the lung collapse. Investigators have also regularly observed this type of obstruction during bronchoscopic examination when positioning the L-DLT.
In past studies comparing L-DLT to BB, time to get CLC was measured from the beginning of OLV. Nevertheless, the interval between this time point and the pleural opening (PO) is sometime difficult to control. Technical incidents can prolong this period and induce a bias. Furthermore, in the last investigator's protocol, the second period of apnea is done at pleural opening. For these reasons, the authors consider that the time to get CLC should be measured from the pleural opening since it is the crucial moment for the surgical team. Investigators are proposing to evaluate the PO-CLC interval as a primary objective.(6)
Hypothesis:
The hypothesis of the proposed study is that the use of the L-DLT will allow for a slower and a poorer quality of CLC compared to the ones obtained with the Rm-DLT in left VATS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left-sided double-lumen tube | – | –Lung isolation with a left-sided double-lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland) |
| Modified right-sided double-lumen tube | – | –Right-sided double-lumen tube modified in accordance with Bussières et al. in Can J Anesth 2007 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing an elective left VATS requiring OLV
Key inclusion criteria (3 listed)
- signed informed consent
- elective left video-assisted thoracoscopy
- one lung ventilation
Key exclusion criteria (14 listed)
- Anticipated difficult mask ventilation or intubation
- tracheal or high bronchial origin of the right upper lobe main bronchus
- severe COPD or asthma
- pleural disease
- previous left thoracic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to obtain complete lung collapse
Time frame: Peroperative
Time to obtain complete lung collapse will be collected from the pleural opening up to complete lung collapse.
5 secondary outcomes
Quality of lung collapse
Time frame: Peroperative
Degree of obstruction of the right upper lobe bronchus lumen
Time frame: Peroperative
Quality of one-lung ventilation
Time frame: Peroperative
Thoracic surgeon's guess about the device used
Time frame: Peroperative
Time between the beginning of one-lung ventilation to pleural opening
Time frame: Peroperative
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 27 Oct 2017.
- Background: PubMed 20058114Slinger P. The clinical use of right-sided double-lumen tubes. Can J Anaesth. 2010 Apr;57(4):293-300. doi: 10.1007/s12630-009-9262-z. No abstract available. English, French.
- Background: PubMed 17171882McKenna MJ, Wilson RS, Botelho RJ. Right upper lobe obstruction with right-sided double-lumen endobronchial tubes: a comparison of two tube types. J Cardiothorac Anesth. 1988 Dec;2(6):734-40. doi: 10.1016/0888-6296(88)90096-8.
- Background: PubMed 17400979Bussieres JS, Lacasse Y, Cote D, Beauvais M, St-Onge S, Lemieux J, Soucy J. Modified right-sided Broncho-Cath double lumen tube improves endobronchial positioning: a randomized study. Can J Anaesth. 2007 Apr;54(4):276-82. doi: 10.1007/BF03022772.
- Background: PubMed 19299766Ko R, McRae K, Darling G, Waddell TK, McGlade D, Cheung K, Katz J, Slinger P. The use of air in the inspired gas mixture during two-lung ventilation delays lung collapse during one-lung ventilation. Anesth Analg. 2009 Apr;108(4):1092-6. doi: 10.1213/ane.0b013e318195415f.
- 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.
- Background: PubMed 11546721Fortier 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.
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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.
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?
An observational study of Video-assisted Thoracoscopic Surgery (VATS) 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 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. 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 to obtain complete lung collapse (time frame: Peroperative). 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 NCT02137291, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.