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临床试验/NCT02951936
NCT02951936撤回不适用

The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Rabin Medical Center0 个研究点开始时间: 2016年12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
撤回
主要终点
number of days ventilated

研究概览

简要总结

Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by NI medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived parameters.

Patients fluid balance will be planned according to these parameters and the rate of liberation from ventilator and rate of worsening renal function will be measured

详细描述

Patients will be divided into two groups , the study group and the control group randomly assigned by a computer program .

After obtaining written informed consent , cardiac monitoring will be carried out by means of a NiCAS patients in both groups.The physician will not be exposed to the measurement data of the patients in the control group. For the research group : Monitoring will be carried out once a day , preferably at the same time the first three days . An increase in time interval is possible in accordance with an improvement in the patient . Patients will be treated according to the protocol described in Figure 1. Also , a graphic description of the various treatment zones and the exclusion zone is presented in Figure 2 .

For the control group patients will be treated according to the usual ward protocols.

The basic rules are:

Avoiding over- drying by using parameter TBW .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All chronically ventilated patients (ventilated for more than 14 days)
  • •Age between 18-90

排除标准

  • •Non ventilated patient
  • •Total body water >80%

研究组 & 干预措施

NiCAS treated

Experimental

Measure each patient with the NiCAS once a day If Cardiac Index < 2.9 +Total Peripheral resistance Index >3000+Mean arterial pressure >70mmHG then add vasodilators.

If Heart Rate<60 consider to reduce beta blockers dose If Cardiac Index>4.2 and Mean arterial pressure 70-100mmHG and HR >100 then add Bata Blockers If patient have low Total Body Water then reduce diuretics If patient have High Total Body Water provide diuretics

干预措施: NiCAS treated (Device)

Non NiCAS treated

Sham Comparator

Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment

干预措施: Non NiCAS treated (Device)

结局指标

主要结局

number of days ventilated

时间窗: 90 days

次要结局

  • kidney function(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Singer

Director of ICU

Rabin Medical Center

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