Safety and Efficacy of Immages System in Patients Recieving IV Therapy

Not Applicable

• Conditions: Sepsis; Bacteriemia; CHF
• Interventions: Device: Sentinel

• Registration Number: NCT02020811
• Lead Sponsor: PRo-IV

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.

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 Timeline

• Status Verified: 2013-05
• Study Start: 2013-11
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-25
• Last Update Posted: 2013-12-25
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sentinel arm	Sentinel	all patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
- Detection of medical errors by IMMAGES	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.

Trial Locations

Locations (1)

Bait Balev hospital; 🇮🇱 Bat Yam, Israel