NCT01317407

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

March 16, 2011

Last Update Submit

March 16, 2011

Conditions

Keywords

postoperative delirium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • absent written consent
  • age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anästhesie und Intensivmedizin, Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Franz Kehl, Professor Dr. med.

CONTACT

Nikolaus A. Golecki, Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2012

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations