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临床试验/NCT06457763
NCT06457763已完成不适用

Comparison of Ultrasound and Classical Method for Left Double Lumen Tube Selection in One-Lung Ventilation: A Randomised Controlled Study

Marmara University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
postoperative cough and sore throat

研究概览

简要总结

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced.

Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2).

Randomisation will be in a 1:1 ratio and will be done by closed envelope method.

详细描述

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced.

In thoracic surgery, single lung ventilation is one of the most challenging airway and ventilation methods for anaesthetists. Bronchial blockers and double lumen tubes are the tools used to isolate the lung in single lung ventilation and double lumen tubes are used more frequently. Size is important when choosing a double lumen tube. There is no definite rule when choosing the tube size. When selecting the size of the double lumen tube, there is a classical method selected according to the gender and height of the patient. However, due to anatomical differences between individuals; inappropriate tube sizes may be selected and this may lead to consequences such as tracheabronchial injury and insufficient deflation of the lungs.

The use of ultrasound can provide rapid assessment of airway anatomy in the operating theatre, intensive care unit and emergency department. Ultrasound is a suitable tool for the evaluation of the subglottic airway confirmed by computed tomography. The use of ultrasound requires less training and the patient does not need to be fully immobilised and sedated. There is a correlation between the diameter of the external trachea measured by ultrasound just above the sternoclavicular junction and the diameter of the left main bronchus measured by computed tomography scan.

Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2).

Randomisation will be in a 1:1 ratio and will be done by closed envelope method. A paper with the name of one of the two groups will be placed in the envelopes beforehand and the envelopes will be closed and mixed. For each patient, a closed envelope will be drawn randomly before the procedure and the procedures will be performed according to the group indicated on the paper.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who will place a left double lumen tube to perform one lung ventilation
  • Between the ages of 18-75
  • ASA 1-2-3 patients

排除标准

  • Patients with a previous history of difficult intubation
  • Patients who have previously undergone head and neck surgery or received radiotherapy
  • Patients with a Cormark-Lehane classification of 3-4 by the thoracic anaesthetist performing intubation,
  • Patients with previous cough and sore throat

研究组 & 干预措施

Ultrasound

Active Comparator

While the patients were in the supine position on the operating room table, the external tracheal diameter, measured just above the sternoclavicular junction, was measured by ultrasound. Appropriately sized tube size was selected in accordance with previous studies and cadaver studies.

干预措施: Ultrasound (Other)

conventional

Active Comparator

For female patients, a 37 fr left double lumen tube was chosen for patients taller than 160 cm, and a 35 fr left double lumen tube was chosen for patients shorter than 160 cm. For male patients, a 41 fr left double lumen tube was selected for patients taller than 170 cm and a 39 fr tube was chosen for men shorter than 170 cm.

干预措施: Ultrasound (Other)

结局指标

主要结局

postoperative cough and sore throat

时间窗: postoperative first at 24 hours

Zero: No sore throat; 1: Mild, sore throat only when swallowing; 2: Moderate, persistent sore throat, aggravated when swallowing; 3: Severe, throat pain affecting the patient's eating, and analgesic drugs were needed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meliha Orhon

Assistant professor

Marmara University

研究点 (1)

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