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临床试验/NCT01254786
NCT01254786已完成2 期

Comparative Study of the Non-dependent Continuous Positive Pressure Ventilation and High Frequency Positive Pressure Ventilation During One-lung Ventilation for Thoracoscopy

King Faisal University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Visual Analog Scale rating of the surgical field conditions

研究概览

简要总结

Video-assisted thoracoscopic surgery (VATS) is usually performed using well-collapsed lung is essential for optimum surgical visualization and resection. However, one lung ventilation (OLV) is associated with deleterious impaired oxygenation secondary to the increases in shunt fraction.1 There are different approaches for the recruitment of the non-dependent lung (NL) during OLV such as the selective application of continuous positive pressure ventilation (CPAP) or high frequency positive pressure ventilation (HFPPV) to the non-dependent lung.2-4 These strategies may improve arterial oxygenation and reduce shunt fraction,2-4 However, the use of high CPAP levels impaired the surgical conditions during thoracotomy.2-3 On contrary, the application of HFPPV either to both lungs5or to the non-dependent lung permits adequate surgical conditions during thoracotomy.4 The investigators hypothesize that the application of volume-controlled HFPPV to the non-dependent lung during OLV for video-assisted thoracoscopic surgery may provide better surgical field and adequate oxygenation than the use of CPAP 2 cm H2O.

The investigators will evaluate the effects of the selective application of conventional one lung ventilation, HFPPV, or CPAP 2 cm H2O to the non-dependent lung on surgical field conditions, and arterial oxygen and carbon dioxide tensions (PaO2 and PaCO2, respectively) during OLV in the patients scheduled for video-assisted thoracoscopic surgery.

详细描述

Thirty patients aged 18-60 years (ASA physical status II-III) scheduled for elective video-assisted thoracoscopic surgery with at least one hour of one-lung ventilation (OLV) will be included in this randomized prospective placebo-controlled crossover study at the authors' center after obtaining approval of the institutional ethical committee and informed written consent. The patients will be randomized to a CPCP2-HFPPV group(n = 15)or a HFPPV-CPAP2 group(n = 15).

A power analysis of the data obtained from our preliminary pilot study indicated that 26 patients will be sufficient to detect a one SD changes in the visual analog scale assessment of the surgical field, with a type-I error of 0.05 and a power of 85%, with added 10% more patients, for a final sample size of 30 patients to account for patients dropping out during the study. All operations will be performed by the same surgeons.

The patients will be premedicated with fentanyl (1.0 μg/Kg) and i.v. midazolam (0.03 mg/Kg). All patients will be monitored with five leads electrocardiography, pulse oximetry, and non-invasive blood pressure and 7mL/Kg of 6% Hydroxyethyl Starch 130/0.4 (Voluven, Fresenius Kabi, Bad Homburg, Germany) will be given intravenously before induction of general anesthesia. An arterial line (20 G) will be inserted under local anesthesia. A thoracic epidural catheter (T4-T7) will be inserted with the patient in sitting position, and a test dose (1.5% lidocaine 3 mL plus epinephrine 1:200.000) will be administered in order to exclude an intravascular or intrathecal position of the catheter. No more epidural local anesthetics will be used during the study in order to avoid effects on hypoxic pulmonary vasoconstriction.

Anesthesiologists who gave the anesthetic will not be involved in the collection of the patient's data. General anesthesia will be induced with propofol (2-3 mg/kg), fentanyl (2-3 µg/kg), and cisatracurium (0.2 mg/kg) was given for muscle relaxation.

The trachea will be intubated with a left-sided double-lumen tube (DLT) [Broncho-Cath®; Mallinckrodt Medical Ltd., Dublin, Ireland]. The correct position of the tube will be confirmed with a fiberoptic bronchoscope after intubation and after positioning the patient in the lateral decubitus position. Other patient monitoring included end-tidal CO2, neuromuscular blockade, and nasopharyngeal temperature will be used. Anesthesia will be maintained with continuous infusions of propofol (6-8 mg/kg/h) and fentanyl (1 µg/kg/h). Increments of cisatracurium (0.03 mg/kg) will be given to maintain suppression of the second twitch using a train-of-four stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • elective video-assisted thoracoscopic surgery with at least one hour of one-lung ventilation (OLV)

排除标准

  • decompensated cardiac diseases(>New York Heart Association II)
  • pulmonary diseases(vital capacity or FEV1% < 50% of the predicted values)
  • hepatic diseases
  • renal diseases
  • arrhythmias
  • pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg)
  • previous history of pneumonectomy
  • bilobectomy
  • lobectomy

结局指标

主要结局

Visual Analog Scale rating of the surgical field conditions

时间窗: every 15 min from the start of surgery

Visual analog Scoring assesment of the surgical field conditions will be rated by the surgeons. VAS of 10 denotes the best surgical fied and VAS of 0 attributes inability to proceed with surgery

次要结局

  • Hemodynamic variables(every 15 min from the start of surgery)
  • Respiratory variables(every 15 min from the start of surgery)

研究者

申办方类型
Other

研究点 (2)

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