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Safety and Efficacy of Immages System in Patients Recieving IV Therapy (IV)

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ClinicalTrials.gov Identifier: NCT02020811
Recruitment Status : Unknown
Verified May 2013 by PRo-IV.
Recruitment status was:  Recruiting
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Collaborator:
Bait Balev Hospital
Information provided by (Responsible Party):
PRo-IV

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sepsis Bacteriemia CHF Device: Sentinel Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy
Study Start Date : November 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: sentinel arm
all patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set.
 Device: Sentinel


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: as long as the patient is reciving the IV prescribed medication, and no longer than 10 days ]

Secondary Outcome Measures :
  1. - Detection of medical errors by IMMAGES [ Time Frame: up to 5 minutes from activating the controller on the IV line ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020811


Contacts
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Contact: Gizele Sasson, MD 972-52-4425581
Contact: michal Devir, MD 972-9-8664128 michal@pro-iv.co.il

Locations
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Israel
Bait Balev hospital Recruiting
Bat Yam, Israel
Contact: Gisele Sasson, MD    972-52-4425581    gisele_s@bbalev.co.il   
Principal Investigator: Gisele Sasson, MD         
Sponsors and Collaborators
PRo-IV
Bait Balev Hospital
Investigators
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Study Chair: michal devir, MD PRo-IV
More Information
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Responsible Party: PRo-IV
ClinicalTrials.gov Identifier: NCT02020811    
Other Study ID Numbers: BBALEV-1
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes