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临床试验/NCT03704038
NCT03704038已完成不适用

Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

University Hospital Dubrava1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年6月1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
发起方
入组人数
33
试验地点
1
主要终点
Change of nondependent / dependent tidal variation

研究概览

简要总结

Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.

Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.

Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).

Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
  • •signed informed consent form

排除标准

  • •preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)
  • •history of organ transplant
  • •disseminated malignant disease
  • •pregnancy

研究组 & 干预措施

PEEP 5

Active Comparator

干预措施: PEEP level (Procedure)

PEEP 0

Active Comparator

干预措施: PEEP level (Procedure)

PEEP 10

Experimental

干预措施: PEEP level (Procedure)

结局指标

主要结局

Change of nondependent / dependent tidal variation

时间窗: Baseline, 10 and 90 minutes post lateral positioning

Measured by EIT

次要结局

  • Change of a-A gradient(Baseline, 10 and 90 minutes post lateral positioning)
  • Duration of hospital stay(Up to 28 days)

研究者

发起方
University Hospital Dubrava
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrej Šribar

Specialist in anesthesiology and intensive are medicine, Principal Investigator

University Hospital Dubrava

研究点 (1)

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