Skip to content

The Utility of Regional Bioimpedance in Chronically Ventilated Patients

The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02951936
Enrollment
0
Registered
2016-11-01
Start date
2016-12-31
Completion date
2019-08-31
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure

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 . * 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 .

Interventions

DEVICENiCAS 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

DEVICENon NiCAS treated

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

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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%

Design outcomes

Primary

MeasureTime frame
number of days ventilated90 days

Secondary

MeasureTime frameDescription
kidney function90 dayswill be assessed by blood test as Creatinin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026