Bronchial Blocker for One-lung Ventilation in Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02729610|
Recruitment Status : Unknown
Verified March 2016 by HailongDong, Xijing Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Complication of Ventilation Therapy Intubation Complication Postoperative; Dysfunction Following Cardiac Surgery||Device: double-lumen endotracheal tube (DLT group) Device: endobronchial blocker (BB group)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Use of Bronchial Blocker Versus Double Lumen Tube for One-lung Ventilation During Thoracoscope Assisted Mitral Valve Replacement|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||October 2016|
Active Comparator: DLT group
In this arm, patient will be intubated with a double lumen endotracheal tube
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
Experimental: BB group
In this arm, patient will be intubated with an endobronchial blocker
Device: endobronchial blocker (BB group)
In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation
- clinically relevant laryngeal and bronchial morbidity [ Time Frame: perioperative period ]incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications
- Heart Rate [ Time Frame: perioperative period ]Heart rate in BPM will be recorded at right before intubation (T1), at intubation (T2), and at three minutes after intubation (T3).
- Central Venous Pressure [ Time Frame: perioperative period ]Central venous pressure in cmH2O will be recorded at right before intubation (T1),at intubation (T2), and at three minutes after intubation (T3).
- Blood Pressure [ Time Frame: perioperative period ]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).
- the Duration of Ventilation [ Time Frame: The duration of ventilation in minutes will be recorded at time from intubation to extubation, an expected average of 18 hours. ]It is the duration of ventilation, prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours
- Length of Postoperative Hospital Stay [ Time Frame: 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 ]Recorded the time of postoperative hospital stay in days.
- Length of CCU Stay [ Time Frame: 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. ]It is the length of stay in cardiac ICU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729610
|Contact: Hailong Dong, MD & PhDfirstname.lastname@example.org|
|Contact: Chong Lei, MD & PhDemail@example.com|
|Principal Investigator:||Hailong Dong, MD & PhD||Xijing Hospital|