The Utility of Regional Bioimpedance in Chronically Ventilated Patients

NCT02951936 | Withdrawn

• 1 other identifier: A1 version 2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• number of days ventilated

  90 days

Secondary Outcomes (1)

• kidney function

  90 days

Study Arms (2)

NiCAS treated

EXPERIMENTAL

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

Non NiCAS treated

SHAM COMPARATOR

Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment

Device: Non NiCAS treated

Interventions

NiCAS treated DEVICE

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

NiCAS treated

Non NiCAS treated DEVICE

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

Non NiCAS treated

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All chronically ventilated patients (ventilated for more than 14 days)
• Age between 18-90

You may not qualify if:

• Non ventilated patient
• Total body water \>80%

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ICU

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share