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临床试验/NCT01183871
NCT01183871已完成1 期

Changes in Cerebral Oxygenation in Patients With Pulmonary Dysfunction After Lung Resection

King Faisal University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
120
试验地点
1
主要终点
jugular bulb oxygenation

研究概览

简要总结

The investigators hypothesize that the lung resection would be associated with lower jugular bulb oxygen saturation in patients with severe pulmonary dysfunction than in patients with healthy lung functions.

详细描述

Surgery remains the treatment of choice for patients with resectable lung cancer. However, a significant proportion of patients undergoing lung resections have the associated condition COPD,1 which increases the risk of perioperative complications and death. New techniques in anesthesiology and critical care have enabled patients with COPD to have better outcomes following lung resections. Nowadays, patients with limited lung function, who would have been denied surgery according to the criteria proposed in the past, may undergo pulmonary resection with a low mortality rate.2

Lung resection results in loss of lung parenchyma including residual healthy lung tissue and in reduction in the pulmonary vascular bed. A decrease in residual pulmonary vascular bed after lung resection causes an increase in the right heart afterload, and in others, it would be associated with an increase in the right heart preload.3

The removal of lung parenchyma from patients with carcinoma of the lung, may lead to cardiopulmonary failure or death. A predicted postoperative forced expiratory volume in one second (FEV1) less than 0.8 to 1.0 liter is considered an indicative of a high risk of postoperative chronic ventilatory insufficiency. After pneumonectomy, FEV1 decreases by 29-35% and forced vital capacity (FVC) decreases by 27-44%. After lobectomy, FEV1 and FVC decrease to12-23% and 10-30%, respectively.4

After lobectomy in patients with normal pulmonary functions, there is a transient good maintenance of gas exchange for only 6-12hours, then it is followed with progressive deterioration in oxygen delivery and intra-pulmonary shunt fraction because of peripheral atelectasis 4-13 days after surgery.5 Other investigators reported a significant decrease in maximal oxygen uptake (VO2-Max) and maximal work rate (WR-Max) by 27% and 42%, respectively, 3 months after pneumonectomy, and by13% and 2%, respectively after lobectomy.

In patients with moderate-to-severe pulmonary dysfunction there is significant worsening of pulmonary gas exchange; especially during one-lung ventilation (OLV) which is the mandatory technique to facilitate thoracic surgery. This worsening is more marked in patients undergoing right thoracotomies after lung resection.6

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (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
否

入选标准

  • •ASA II-IV
  • •Ages 18-60 yrs.
  • •Good or impaired pulmonary function tests

排除标准

  • •Decompensated cardiac function (>New York Heart Association II).
  • •Hepatic and renal diseases
  • •Arrhythmias
  • •Moderate pulmonary hypertension (mean pulmonary artery pressure (MPAP) >35 mm Hg),
  • •Previous history of pneumonectomy, bilobectomy or lobectomy
  • •Cervical spine injury
  • •Tracheostomy
  • •Coagulopathy

研究组 & 干预措施

good pulmonary functions (group 1)

Active Comparator

FVC and/or FEV1 of 80% of predicted or more

干预措施: Monitoring of cerebral oxygenation (Procedure)

mild pulmonary dysfunction (group 2)

Active Comparator

FVC and/or FEV1 of 70%-79% of predicted

干预措施: Monitoring of cerebral oxygenation (Procedure)

moderate pulmonary dysfunction (group 3)

Active Comparator

FVC and/or FEV1 of 60%-69% of predicted

干预措施: Monitoring of cerebral oxygenation (Procedure)

severe pulmonary dysfunction (group 4)

Active Comparator

FVC and/or FEV1 of 50%-59% of predicted

干预措施: Monitoring of cerebral oxygenation (Procedure)

结局指标

主要结局

jugular bulb oxygenation

时间窗: before (baseline) and15 min after induction of anesthesia during two-lung ventilation, 15, 30, 60 min after OLV, and 15 min after resuming of two-lung ventilation (TLV), and 1, 4, 6, 12, 18 and 24 hrs after recovery.

jugular bulb oxygen saturation (SjvO2), estimated cerebral metabolic rate of oxygen \[CMRO2\], cerebral extraction of oxygen \[CEO2\], cerebral blood flow equivalent \[CBFE\], and arterial to jugular difference in oxygen content (AjvDO2)

次要结局

  • Respiratory and Hemodynamic Data(baseline and15 min after induction of anesthesia during two-lung ventilation,1, 4, 6, 12, 18 and 24 hrs after recovery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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