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临床试验/NCT02729610
NCT02729610Unknown4 期

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

Xijing Hospital0 个研究点目标入组 58 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
58
主要终点
clinically relevant laryngeal and bronchial morbidity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

clinically relevant laryngeal and bronchial morbidity

时间窗: perioperative period

incidence of clinically relevant laryngeal and bronchial morbidity will be recorded, including postoperative hoarseness, sore throat, and vocal cord injuries, pulmonary complications

次要结局

  • Central Venous Pressure(perioperative period)
  • Blood Pressure(perioperative period)
  • 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)
  • 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.)
  • Heart Rate(perioperative period)
  • Length of CCU Stay(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.)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

HailongDong

Professor & Chief of Department of Anesthesiology

Xijing Hospital

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