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临床试验/NCT04329416
NCT04329416已完成不适用

Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年5月7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
65
试验地点
1
主要终点
The rate of optimum position of the double-lumen tube

研究概览

简要总结

The authors developed a formula for predicting the accurate depth of DLT insertion into the appropriate bronchus based on height as follows [The predicted insertion depth of left DLT (cm) equals 0.249 × (BH)0.916] [R]. That pilot study showed comparable correlations between five formulae [Brodsky et al, Bahk and Oh R, Takita et al, Chow et al, Lin]. However, that formula developed has not been validated yet.

We hypothesized that previously published formula would predict the accurate depth of left-sided DLT insertion. We aimed to investigate the efficacy of this formula to estimate the optimum insertion depth of the DLT using a flexible bronchoscope and decrease the incidence of DLT displacement into the appropriate bronchus, the need for bronchoscopic adjustment, and complications including soreness of throat and mucosal injury.

详细描述

Accurate placement of the double-lumen tube [DLT], the commonly used tool to provide one-lung ventilation during thoracic surgery, is a real challenge for the thoracic anesthesiologists. Optimal DLT depth, defined as the blue endobronchial cuff below the carina, would decrease the incidence of obstructing the trachea and the contralateral bronchus (Brodsky). Additionally, deep insertion of the bronchial cuff of the DLT would obstruct the upper lobe bronchus (Brodsky). The careful adjustment of the depth and optimal positioning of the DLT using a flexible fiberoptic bronchoscope need a skilled anesthesiologist to reduce the time to DLT intubation. (Charles D. Boucek et al)

There are several methods have been described to predict the proper depth of DLT insertion. Chow et al. documented the validity of the developed formula based on the clavicular-to-carinal distance of trachea and height in 78% of patients studied. Brodsky et al. demonstrated that a height-and-gender-based formula could predict the depth of DLT insertion. Liu et al. reported an accurate depth of DLT insertion in 90% of patients studied measuring the distance between the vocal cord and carina according to the chest CT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Underwent thoracic surgery
  • •Using a left-sided double-lumen tube for one-lung ventilation

排除标准

  • •Anticipated or known difficult airway
  • •Refuse to sign the consent
  • •Withdraw the consent

研究组 & 干预措施

Predicted depth of insertion

Other

The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] before induction of anesthesia using an application on the smartphone

干预措施: Predicted depth of insertion (Other)

Predicted depth of insertion

Other

The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] before induction of anesthesia using an application on the smartphone

干预措施: Optimized depth of insertion (Other)

Predicted depth of insertion

Other

The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] before induction of anesthesia using an application on the smartphone

干预措施: Adjustment of depth of insertion (Other)

结局指标

主要结局

The rate of optimum position of the double-lumen tube

时间窗: for 15 minutes after double-lumen tube insertion

The rate of optimum position of a left-sided DLT without further adjustments, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation

次要结局

  • Changes in heart rate(for 25 minutes after double-lumen tube insertion)
  • The need for bronchoscopic adjustments(for 15 minutes after double-lumen tube insertion)
  • Changes in peripheral oxygen saturation(for 25 minutes after double-lumen tube insertion)
  • The incidence of soreness of throat(for 24 hours after start of surgery)
  • Position of the double-lumen tube with the flexible bronchoscope(for 15 minutes after double-lumen tube insertion)
  • The final correct depth of insertion(for 15 minutes after double-lumen tube insertion)
  • The calculated predicted depth of insertion(immediately before induction of general anesthesia)
  • The initial depth of insertion(for 15 minutes after double-lumen tube insertion)
  • Time to final correct double-lumen tube positioning(for 25 minutes after double-lumen tube insertion)
  • Changes in mean arterial blood pressure(for 25 minutes after double-lumen tube insertion)
  • Degree of lung collapse(for 30 minutes after start of surgery)
  • The incidence of mucosal injury(for 40 minutes after double-lumen tube insertion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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