The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Chronic Respiratory Failure Clinical Trial

Official title:

The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02951936
• Other study ID #: A1 version 2
• Status: Withdrawn
• Phase: N/A
• First received: September 4, 2016
• Last updated: February 11, 2018
• Start date: December 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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%

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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
• Non 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of days ventilated		90 days
Secondary	kidney function	will be assessed by blood test as Creatinin	90 days