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Bronchial Blocker for One-lung Ventilation in Cardiac Surgery

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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
Sponsor:
Information provided by (Responsible Party):
HailongDong, Xijing Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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

  5. 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.

  6. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Hailong Dong, MD & PhD 86-29-84775337 hldong6@hotmail.com
Contact: Chong Lei, MD & PhD 86-29-84775337 leichongbb@gmail.com

Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Hailong Dong, MD & PhD Xijing Hospital
Publications:

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Responsible Party: HailongDong, Professor & Chief of Department of Anesthesiology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02729610    
Other Study ID Numbers: KY20153001-1
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided