跳至主要内容
临床试验/CTRI/2023/03/050319
CTRI/2023/03/050319已完成不适用

A prospective observational study to assess the safety and efficacy following the use of the right-sided double-lumen tubes for elective thoracic surgeries.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
The incidence of intra-operative hypoxia associated with the use of Right-sided double lumen tube

研究概览

简要总结

One-lung ventilation is a procedure where one of the two lungs is ventilated while the other one is not ventilated. It facilitates minimally invasive surgery. Double-lumen tubes (DLTs) are the most commonly used devices for one-lung ventilation. Both right and left-sided DLTs are available. However, left-sided DLTs are commonly used as Right-sided DLTs carry a risk of lack of ventilation to the upper part of the right lung. It leads to a drop in the level of oxygen in the blood. However, with the use of pediatric bronchoscopes, it is now possible to avoid this complication during surgery by achieving the correct position of the right-sided DLTs.

Hence, we wish to do a prospective, observational study to know the safety and efficacy associated with right-sided DLTs.

Written informed consent will be taken a day prior to surgery.

 We will observe the process of insertion of right-sided DLTs, the incidence of intraoperative drop in the oxygenation, and the postoperative complications related to the lungs.

 The patient will be followed up from the day of surgery till discharge from the hospital for any post-operative pulmonary complications.

There is no risk involved to the patient by participating in the study, as it is a purely observational study.

The patient’s identity will be kept confidential throughout the study.

The patient can withdraw from the study at any point in time. The clinical management of the patient won’t be affected by the decision to participate or withdraw from the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All adult patients undergoing one-lung ventilation using right-sided DLTs placed in the right main bronchus.

排除标准

  • 1.Emergency surgery 2.Patient < 18 years of age 3.Endobronchial masses inside the trachea, right mainstem bronchus (RMB), or bronchus intermedius (BI) 4.Radiological evidence of compression or deviation of the trachea, RMB, or BI.
  • 5.Patients planned for right pneumonectomy/right bronchial sleeve surgery or right bronchotomy.
  • 6.Patient with anatomical variation in the trachea e.g. Pig Bronchus 7.Patients with a height of less than 150 cm 8.Patients with tracheostomy or anticipated difficult airway.

结局指标

主要结局

The incidence of intra-operative hypoxia associated with the use of Right-sided double lumen tube

时间窗: at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation.

次要结局

  • the time taken for the insertion of RDLT, number of attempts of intubation, rate of first attempt success, and rate of dislodgement of RDLT(at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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