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

December 19, 2013 updated by: PRo-IV

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Bat Yam, Israel
        • Recruiting
        • Bait Balev hospital
        • Contact:
        • Principal Investigator:
          • Gisele Sasson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
as long as the patient is reciving the IV prescribed medication, and no longer than 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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.
up to 5 minutes from activating the controller on the IV line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PRo-IV

Collaborators

Bait Balev Hospital

Investigators

  • Study Chair: michal devir, MD, PRo-IV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBALEV-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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