The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Primary Purpose
Chronic Respiratory Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NiCAS treated
Non NiCAS treated
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Respiratory Failure
Eligibility Criteria
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%
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NiCAS treated
Non NiCAS treated
Arm Description
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
Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment
Outcomes
Primary Outcome Measures
number of days ventilated
Secondary Outcome Measures
kidney function
will be assessed by blood test as Creatinin
Full Information
NCT ID
NCT02951936
First Posted
September 4, 2016
Last Updated
February 11, 2018
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02951936
Brief Title
The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Official Title
The Utility of Regional Bioimpedance in Chronically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulties in recrutment
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NiCAS treated
Arm Type
Experimental
Arm Description
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
Arm Title
Non NiCAS treated
Arm Type
Sham Comparator
Arm Description
Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment
Intervention Type
Device
Intervention Name(s)
NiCAS treated
Intervention Description
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 Type
Device
Intervention Name(s)
Non NiCAS treated
Intervention Description
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
Primary Outcome Measure Information:
Title
number of days ventilated
Time Frame
90 days
Secondary Outcome Measure Information:
Title
kidney function
Description
will be assessed by blood test as Creatinin
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Utility of Regional Bioimpedance in Chronically Ventilated Patients
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