One-lung Ventilation Clinical Trial
— IPg2Official title:
IPg2 Study - Left-sided Lung Isolation: Comparison of Twodevices
Verified date | October 2017 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Institut universitaire de cardiologie et de pneumologie de Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Canada,
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. — View Citation
Bussières JS, Lacasse Y, Côté 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. — View Citation
Fortier G, Coté D, Bergeron C, Bussières 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. — View Citation
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. — View Citation
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. — View Citation
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. English, French. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to obtain complete lung collapse | Time to obtain complete lung collapse will be collected from the pleural opening up to complete lung collapse. | Peroperative | |
Secondary | Quality of lung collapse | Quality of lung collapse from de beginning of one-lung ventilation to the end of surgery | Peroperative | |
Secondary | 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 | Peroperative | |
Secondary | Quality of one-lung ventilation | Quality of one-lung ventilation from de beginning of one-lung ventilation to the end of surgery | Peroperative | |
Secondary | 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 | Peroperative | |
Secondary | 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 | Peroperative |
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