Bronchial Blocker for One-lung Ventilation in Cardiac Surgery
The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement
1 other identifier
interventional
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedApril 6, 2016
March 1, 2016
6 months
March 21, 2016
March 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Heart Rate
perioperative period
Central Venous Pressure
perioperative period
Blood Pressure
perioperative period
the Duration of Ventilation
The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours.
Length of Postoperative Hospital Stay
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
- +1 more secondary outcomes
Study Arms (2)
DLT group
ACTIVE COMPARATORIn this arm, patient will be intubated with a double lumen endotracheal tube
BB group
EXPERIMENTALIn this arm, patient will be intubated with an endobronchial blocker
Interventions
In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation
In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation
Eligibility Criteria
You may qualify if:
- New York Heart Association (NYHA)I-III level.
- scheduled for thoracoscope assisted mitral valve surgery under surgery
- provide with informed consent.
You may not qualify if:
- emergency surgery.
- preoperative pulmonary diseases, such as chronic obstructive pulmonary disease, atelectasis.
- preoperative voice hoarse or sore throat.
- involved in other clinical trials within 3 months .
- Cannot cooperate with language understanding disorders or psychological problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Related Publications (6)
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.
PMID: 24231197BACKGROUNDKuo 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.
PMID: 24021918BACKGROUNDGuo 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.
PMID: 25152290BACKGROUNDRothfield 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.
PMID: 23101777BACKGROUNDRuetzler 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.
PMID: 21493621BACKGROUNDLei 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.
PMID: 24139456BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Hailong Dong, MD & PhD
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Chief of Department of Anesthesiology
Study Record Dates
First Submitted
March 21, 2016
First Posted
April 6, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
April 6, 2016
Record last verified: 2016-03