IPg2 Study: Left-sided Lung Isolation

NCT02137291 | Completed

• 1 other identifier: IUCPQ-20952
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of lung collapse

  Peroperative

• Degree of obstruction of the right upper lobe bronchus lumen

  Peroperative

• Quality of one-lung ventilation

  Peroperative

• Thoracic surgeon's guess about the device used

  Peroperative

• Time between the beginning of one-lung ventilation to pleural opening

  Peroperative

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing an elective left VATS requiring OLV

You may qualify if:

• signed informed consent
• elective left video-assisted thoracoscopy
• one lung ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Related Publications (6)

• 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.

  PMID: 20058114 BACKGROUND

• 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.

  PMID: 17171882 BACKGROUND

• 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.

  PMID: 17400979 BACKGROUND

• 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.

  PMID: 19299766 BACKGROUND

• 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.

  PMID: 15950850 BACKGROUND

• 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.

  PMID: 11546721 BACKGROUND

Study Officials

• Jean S Bussières, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Full clinical professor

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (1)