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临床试验/NCT07191002
NCT07191002招募中不适用

The Role of Existing Formulas and Airway Measurements in Determining the Appropriate Placement Depth of the Double-lumen Tube in Thoracic Surgery Anesthesia: a Prospective Observational Study

Ankara Ataturk Sanatorium Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
consistency between the DLT depths calculated using six different formulas

研究概览

简要总结

In most clinical scenarios, left DLT is preferred for one-lung ventilation because of its anatomical ease of placement; these tubes allow separate ventilation of both lungs. If the DLT is not placed in the proper size and depth, it may result in repeated intubation attempts, airway and dental trauma, failed lung isolation, tube dislodgement, and various unwanted events such as hypoxemia.

The first and most common method for correct placement of a DLT is the conventional technique, blindly advanced into the left main bronchus, and then confirmed with fiberoptic bronchoscopy (FOB). In this method, the depth at which the tube should be left before performing FOB is left to the clinician's experience. Generally, the DLT is advanced in the trachea until a slight resistance is felt. This may lead to excessive advancement of the DLT into the left main bronchus or premature resistance due to the tube tip touching the carina, causing the clinician to stop before entering the left main bronchus. Therefore, just as selecting the correct size of the DLT is crucial, correctly estimating the appropriate depth is also of great importance. For this reason, different formulas have been proposed in the literature, and new formulas are still being investigated.

The patient's gender and height are determinant in selecting the appropriate size of the DLT. However, studies in the literature indicate that the accuracy of these formulas may be limited in Asian populations. Therefore, it is important to evaluate the applicability of these formulas in different populations and, if necessary, develop new formulas. In the Turkish population as well, verifying the accuracy of these formulas for determining the proper size and depth of DLT-and if needed, developing new recommendations and formulas-holds clinical importance.

In this study, conducted at Ankara Atatürk Sanatorium Training and Research Hospital, the aim is to evaluate the accuracy of six different formulas available in the literature for predicting DLT depth in patients undergoing thoracic surgery. Additionally, the correlations between DLT depth and demographic parameters as well as external airway measurements (mouth opening, sternomental distance, thyromental distance, distance between the mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) will be analyzed. Furthermore, challenges during DLT application, malposition rates and types, and complications will be assessed.

The primary objective of this study is to evaluate, in patients undergoing thoracic surgery at Ankara Atatürk Sanatorium Training and Research Hospital, how accurate and applicable six different formulas defined in the literature are for predicting the placement depth of the DLT. If the existing formulas are insufficient, the aim is to develop a new formula.

详细描述

Hypothesis H0 (Null Hypothesis): The formulas defined in the literature accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, no additional measurement methods are required.

H1 (Alternative Hypothesis): The formulas defined in the literature do not accurately predict the placement depth of the left double-lumen tube (DLT) in the Turkish population; therefore, DLT placement depth can be predicted more accurately using external anatomical parameters and population-specific measurement methods, and additional measurement methods are required.

Study Design The study has been designed as a single-center, prospective observational study.

Study Setting/ Location The study will be conducted at Ankara Atatürk Sanatorium Training and Research Hospital, in the Department of Anesthesiology and Reanimation, Thoracic Surgery operating room.

Study Population The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients older than 18 and younger than 80 years
  • •Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
  • •Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
  • •Patients with a body mass index (BMI) between 18-40 kg/m²
  • •Patients who provide informed consent

排除标准

  • •Patients requiring right DLT placement
  • •Patients with ASA score IV and above
  • •Patients intubated with a single-lumen tube
  • •Patients in whom lung isolation will be achieved with a method other than DLT
  • •Emergency cases
  • •Patients younger than 18 or older than 80 years

结局指标

主要结局

consistency between the DLT depths calculated using six different formulas

时间窗: during perioperative

The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ramazan Baldemir

Clinic Associate Professor

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

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