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临床试验/NCT03508050
NCT03508050已完成不适用

Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation

Jean Bussières2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
T50-3

研究概览

简要总结

Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it.

The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air.

The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.

This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).

详细描述

One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated.

Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening.

A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas.

Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group.

Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV.
  • More than 18 years old.
  • Having read, understand and signed the consent form presented at the pre-operative evaluation
  • Exclusion criteria :
  • A- Pre-operative
  • Known or anticipated difficult tracheal intubation.
  • Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
  • Severe COPD or asthma (FEV1 <50%).
  • Prior intrathoracic surgery (including cardiac surgeries).
  • Pleural or interstitial pathology.
  • Previous chemotherapy or thoracic radiotherapy.
  • Acute or chronic pulmonary infection.
  • Endobronchial mass.
  • Tracheostomy.
  • B- Post-randomisation
  • Bronchoscopic findings contraindicating the insertion of DLT.
  • VATS findings that cancel the surgery.
  • Severe desaturation (SatO2 < 90%) during the observation period.
  • Any need to reinflate the collapse lung.

排除标准

  • 未提供

结局指标

主要结局

T50-3

时间窗: From the beginning of surgery (pleural opening) until 120 minutes

Moment where the probability of having a complete lung collapse is 50%

次要结局

  • Complete Lung Collapse (CLC-clinical)(From the beginning of surgery (pleural opening) until 60 minutes)
  • O2 Concentration of Expired Air at Pleural Opening(From pleural opening and lasting 60 seconds)
  • Expiratory Volume at Pleural Opening(From pleural opening and lasting 60 seconds)
  • O2 Concentration of Expired Air at the Beginning of One-lung Ventilation(From the beginning of one-lung ventilation and lasting 60 seconds)
  • Optimization of Lung Collapse(From the beginning of surgery (pleural opening) until 60 minutes)
  • Quality of Oxygenation During One-lung Ventilation (PaO2 )(25 minutes after pleural opening)
  • Quality of Oxygenation During One-lung Ventilation (SaO2)(25 minutes after pleural opening)
  • Surgery Duration(From the beginning of surgery (pleural opening) until 120 minutes)
  • Postoperative Atelectasis(End of hospitalization)
  • Quality of Lung Collapse (Clinical) at 0 Minute(At pleural opening (0 minute))
  • Quality of Lung Collapse (Clinical) at 10 Minutes(10 minutes after pleural opening)
  • Quality of Lung Collapse (Clinical) at 20 Minutes(20 minutes after pleural opening)

研究者

发起方
Jean Bussières
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Bussières

Anesthesiologist

Laval University

研究点 (2)

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