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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Withdrawn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
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 4, 2016
    Last Updated
    February 11, 2018
    Sponsor
    Rabin Medical Center
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    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    Withdrawn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

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    The Utility of Regional Bioimpedance in Chronically Ventilated Patients

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