Clinical trial NCT02137291: IPg2 Study: Left-sided Lung Isolation
Official title: IPg2 Study - Left-sided Lung Isolation: Comparison of Twodevices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Video-assisted Thoracoscopic Surgery (VATS)
One-lung Ventilation
Keywords: Video-assisted thoracoscopic surgery (VATS)
Lung isolation device
One-lung ventilation
Double lumen endotracheal tube
Bronchial blocker
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an elective left VATS requiring OLV

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to obtain complete lung collapse
timeFrame: Peroperative
Secondary outcomes:
measure: Quality of lung collapse
timeFrame: Peroperative
measure: Degree of obstruction of the right upper lobe bronchus lumen
timeFrame: Peroperative
measure: Quality of one-lung ventilation
timeFrame: Peroperative
measure: Thoracic surgeon's guess about the device used
timeFrame: Peroperative
measure: Time between the beginning of one-lung ventilation to pleural opening
timeFrame: Peroperative
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Laval University
name: Jean S Bussières, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available. English, French.
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. doi: 10.1016/0888-6296(88)90096-8.
citation: 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.
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.
citation: 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.
citation: 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.