The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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 . Avoidance of renal dysfunction by maintaining the cardiac output above 2.3 , and avoiding the use of beta-blocker overdose in cases of low cardiac output and bradycardia as a result of maintaining an average blood pressure over 70 . In cases of high peripheral resistance - Reduction of resistance while maintaining normal blood pressure .

Official Title
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The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Device: NiCAS treated
* Device: Non NiCAS treated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All chronically ventilated patients (ventilated for more than 14 days) Age between 18-90 Exclusion Criteria: Non ventilated patient Total body water >80%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NiCAS treated<br>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 | Device: NiCAS treated<br>* 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<br>|
| Sham Comparator: Non NiCAS treated<br>Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment | Device: Non NiCAS treated<br>* Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment For treatment we will use the standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days ventilated |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function | will be assessed by blood test as Creatinin | 90 days |