Safety and Efficacy of Immages System in Patients Recieving IV Therapy

Sepsis Clinical Trial

— IV  

Official title:

A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02020811
• Other study ID #: BBALEV-1
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2013
• Last updated: December 19, 2013
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2013
• Source: PRo-IV
• Contact: Gizele Sasson, MD
• Phone: 972-52-4425581
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.

Description:

Using the IMMAGES system in patients recieving IV therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria:

1. Patients requiring infusion therapy

2. Patients receiving infusion therapy by gravity flow or by pump

3. patients are scheduled to receive at least once a day an infusion therapy

4. Patients are scheduled to receive an infusion therapy for at least 3 days

5. Adult over age of 18 years

6. Informed consent form signed by patient.

Exclusion Criteria:

1. Informed consent form not signed

2. Patients are scheduled to receive less than once a day an infusion therapy

3. patients to receive less than 3 days of infusion therapy

4. patients not hospitalized in a ward that is participating in the study.

5. patients participating in another clinical study or clinical field test

6. Patients require isolation treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bacteremia
• Bacteriemia
• CHF
• Sepsis

Intervention

Device:
• Sentinel

Locations

Country	Name	City	State
Israel	Bait Balev hospital	Bat Yam

Sponsors (2)

Lead Sponsor	Collaborator
PRo-IV	Bait Balev Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful operation of IMMAGES defined by patient receiving the prescribed IV medication using the IMMAGES system , openning of the controller valve including using the smartphone application and the management software		as long as the patient is reciving the IV prescribed medication, and no longer than 10 days	Yes
Secondary	- Detection of medical errors by IMMAGES	If there is an error related to administration of wrong drug. to the wrong patient , on the wrong timing - the valve of the controller will not open , and the IV line will stay closed, and the patient will not get the wrong drug.	up to 5 minutes from activating the controller on the IV line	Yes