Automated Visual Monitoring for Improving Patient Safety... | NCT01317407

Studies
Automated Visual Monitoring for Improving Patient Safety (VIPSafe)

NCT01317407

Sponsor

Staedtisches Klinikum Karlsruhe

Status

Unknown status

Last Update Posted

Mar 17, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Postoperative Confusion

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2011

Last Update Posted Date

Mar 17, 2011Estimated

Name	Class
Karlsruhe Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

After an operation many patients are in a confused mental status at the intensive care unit. In this status they possibly fall out of their bed or pull out endotracheal tubes or central venous catheters accidentally. For this, they need permanently monitoring and control through intensive care personnel.

The goal of the VIPSafe project is to develop robust techniques for automated patient monitoring, that rely on data from a small number of untethered sensors, which are nonetheless flexible enough to cope with a large variety of demands.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with planned postoperative stay at intensive care unit after previous written consent to the study
patients with not-planned postoperative stay at intensive care unit with written consent after admission to intensive care unit
patients unfit to plead with admission to intensive care unit with written consent of the officially appointed agent

Exclusion Criteria:

absent written consent
age < 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a planned or not-planned stay at the intensive care unit after an operation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Franz Kehl, Professor Dr. med.	Contact	++49-721-974-1601		franz.kehl@klinikum-karlsruhe.de
Nikolaus A. Golecki, Dr. med.	Contact	++49-721-974-0		nikolaus.golecki@klinikum-karlsruhe.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesie und Intensivmedizin, Städtisches Klinikum Karlsruhe		Karlsruhe		76133	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided