Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

Intubation Complication Clinical Trial

Official title:

The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02729610
• Other study ID #: KY20153001-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 21, 2016
• Last updated: March 31, 2016
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2016
• Source: Xijing Hospital
• Contact: Hailong Dong, MD & PhD
• Phone: 86-29-84775337
• Email: hldong6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Intubation Complication
• Postoperative; Dysfunction Following Cardiac Surgery

Intervention

Device:
• double-lumen endotracheal tube (DLT group)
In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation
• endobronchial blocker (BB group)
In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

References & Publications (6)

Guo C, Ma C, Yu L. [Comparative of coopdech bronchial blocker and double-lumen tube on one lung ventilation in children]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1651-3. Chinese. — View 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. — View 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. — View Citation

Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically relevant laryngeal and bronchial morbidity	incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications	perioperative period	Yes
Secondary	Heart Rate	Heart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).	perioperative period	Yes
Secondary	Central Venous Pressure	Central venous pressure in cmH2O will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).	perioperative period	Yes
Secondary	Blood Pressure	Systolic blood pressure, diastolic blood pressure and mean arterial pressure all in mmHg will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).	perioperative period	Yes
Secondary	the Duration of Ventilation	It is the duration of ventilation, prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours	The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.	No
Secondary	Length of Postoperative Hospital Stay	Recorded the time of postoperative hospital stay in days.	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	No
Secondary	Length of CCU Stay	It is the length of stay in cardiac ICU	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.	No