- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137291
IPg2 Study: Left-sided Lung Isolation (IPg2)
IPg2 Study - Left-sided Lung Isolation: Comparison of Twodevices
Study Overview
Status
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 (Unpublished data)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 (Unpublished data) Further to complementary analysis, investigators have noted a significant difference in time to get complete lung collapse between left and right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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- signed informed consent
- elective left video-assisted thoracoscopy
- one lung ventilation
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Left-sided double-lumen tube
Lung isolation with a left-sided double-lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland)
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Modified right-sided double-lumen tube
Right-sided double-lumen tube modified in accordance with Bussières et al. in Can J Anesth 2007
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to obtain complete lung collapse
Time Frame: Peroperative
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Time to obtain complete lung collapse will be collected from the pleural opening up to complete lung collapse.
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Peroperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of lung collapse
Time Frame: Peroperative
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Quality of lung collapse from de beginning of one-lung ventilation to the end of surgery
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Peroperative
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Degree of obstruction of the right upper lobe bronchus lumen
Time Frame: Peroperative
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Degree of obstruction of the right upper lobe bronchus lumen from de beginning of one-lung ventilation to the end of surgery
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Peroperative
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Quality of one-lung ventilation
Time Frame: Peroperative
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Quality of one-lung ventilation from de beginning of one-lung ventilation to the end of surgery
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Peroperative
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Thoracic surgeon's guess about the device used
Time Frame: Peroperative
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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
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Peroperative
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Time between the beginning of one-lung ventilation to pleural opening
Time Frame: Peroperative
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Time between the beginning of one-lung ventilation to pleural opening from de beginning of one-lung ventilation to the pleural opening
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Peroperative
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- McKenna 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.
- Bussieres 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.
- Ko 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.
- Brodsky 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.
- Fortier 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IUCPQ-20952
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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