Clinical trial NCT02729610: Bronchial Blocker for One-lung Ventilation in Cardiac Surgery
Official title: The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Complication of Ventilation Therapy
Intubation Complication
Postoperative; Dysfunction Following Cardiac Surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate if bronchial blocker is more suitable for one-lung ventilation during thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the double-lumen endobronchial tube.

Detailed description: Postoperative hoarseness, sore throat, and vocal cord injuries are common complications after general anesthesia. The incidence of postoperative hoarseness is as frequent as 50% after short-term tracheal intubation. In the past, several risk factors for postoperative hoarseness and laryngeal injury have been identified, including demographic factors, quality of tracheal intubation and technical factors such as endotracheal tube size. One-lung ventilation during thoracotomy can be achieved via two basic techniques: (1) use of a double-lumen endotracheal tube (DLT) consisting of an endotracheal and an endobronchial lumen allowing independent single-lung ventilation ; or (2) use of an endobronchial blocker such as the Arndt blocker, which allows lung collapse distal to the occlusion. It has been recently demonstrated that DLT and endobronchial blocker are similar in their efficacy to achieve lung isolation for elective thoracic surgery. No data are available yet about the influence of the chosen technique on postoperative hoarseness, vocal cord injuries, sore throat, and bronchial injuries. Published data of Stout et al. imply that the incidence of postoperative hoarseness and vocal cord injury might be directly correlated with size of the used endotracheal tube. During thoracoscope assisted mitral valve replacement cardiac surgery, excellent lung isolated was not required. One-lung ventilation with the other lung collapsed is used to achieve a better exposure and assist the surgery. During the cardiac surgery under cardiopulmonary bypass, heparinization will lead to uncontrolled hemorrhage if there is endotracheal tube insertion associated injury. In addition, DLTs need to be exchanged for a single-lumen tube before the patient transferring to cardiac care unit for postoperative ventilatory support. This may result in second time injury. Investigators hypothesized that using a bronchial blocker to achieve one-lung ventilation may result in a lower incidence of clinically relevant laryngeal and bronchial morbidity after thoracoscope assisted mitral valve replacement cardiac surgery compared with a control group intubated with a DLT.

Eligibility criteria: Inclusion Criteria:

1. New York Heart Association (NYHA)I-III level.
2. scheduled for thoracoscope assisted mitral valve surgery under surgery
3. provide with informed consent.

Exclusion Criteria:

1. emergency surgery.
2. preoperative pulmonary diseases, such as chronic obstructive pulmonary disease, atelectasis.
3. preoperative voice hoarse or sore throat.
4. involved in other clinical trials within 3 months .
5. Cannot cooperate with language understanding disorders or psychological problems.

Primary outcomes:
measure: clinically relevant laryngeal and bronchial morbidity
timeFrame: perioperative period
Secondary outcomes:
measure: Heart Rate
timeFrame: perioperative period
measure: Central Venous Pressure
timeFrame: perioperative period
measure: Blood Pressure
timeFrame: perioperative period
measure: the Duration of Ventilation
timeFrame: The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
measure: Length of Postoperative Hospital Stay
timeFrame: Length of postoperative hospital stay in days will be recorded which is defined as the time from surgery to hospital discharge, an expected average of 10 days
measure: Length of CCU Stay
timeFrame: Length of CCU stay in hours will be recorded which is defined as the time stay in the cardiac intensive care unit, an expected average of 3 days.
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Hailong Dong, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoo JY, Kim DH, Choi H, Kim K, Chae YJ, Park SY. Disconnection technique with a bronchial blocker for improving lung deflation: a comparison with a double-lumen tube and bronchial blocker without disconnection. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):904-7. doi: 10.1053/j.jvca.2013.07.019. Epub 2013 Nov 11.
citation: Kuo AS, Philip JH, Edrich T. Airway ventilation pressures during bronchoscopy, bronchial blocker, and double-lumen endotracheal tube use: an in vitro study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):873-9. doi: 10.1053/j.jvca.2013.03.023. Epub 2013 Sep 7.
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citation: Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.
citation: Lei Q, Zeng QS, Zhang XS, Xie B, Luo ZC, Guo HM, Chen JM, Zhuang J. Superior vena cava drainage during thoracoscopic cardiac surgery: bilateral internal jugular vein sheaths versus one percutaneous superior vena cava cannula. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):914-8. doi: 10.1053/j.jvca.2013.05.043. Epub 2013 Oct 16.