The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Rabin Medical Center
- Primary Endpoint
- number of days ventilated
Study Overview
Brief Summary
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
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Arms & Interventions
NiCAS treated
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
Intervention: NiCAS treated (Device)
Non NiCAS treated
Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment
Intervention: Non NiCAS treated (Device)
Outcomes
Primary Outcomes
number of days ventilated
Time Frame: 90 days
Secondary Outcomes
- kidney function(90 days)
Investigators
Pierre Singer
Director of ICU
Rabin Medical Center