Postoperative ConfusionVIPSafeNCT01317407
Automated Visual Monitoring for Improving Patient Safety (VIPSafe)
An observational study of Postoperative Confusion, run by Staedtisches Klinikum Karlsruhe at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Confusion
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a planned or not-planned stay at the intensive care unit after an operation
Who may be able to join
- 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
Who cannot join
- absent written consent
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anästhesie und Intensivmedizin, Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Franz Kehl, Professor Dr. med., ++49-721-974-1601
About this study
Official title: Automatisierte Optische Überwachung Mittels Videosensorik Zur Verbesserung Der Patientensicherheit Auf Intensivstation (Automated Visual Monitoring for Improving Patient Safety (VIPSafe))
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.
- Conditions
- Postoperative Confusion
- Keywords
- postoperative delirium
- Medical subject headings
- Emergence Delirium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staedtisches Klinikum Karlsruhe
- Sponsor type
- University, hospital or other
- Collaborators
- Karlsruhe Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317407
- Sponsor's protocol ID
- SKKarlsruhe-VIPSafe
- Acronym
- VIPSafe
- Status last verified
- Mar 2011
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatisierte Optische Überwachung Mittels Videosensorik Zur Verbesserung Der Patientensicherheit Auf Intensivstation (Automated Visual Monitoring for Improving Patient Safety (VIPSafe))
- ClinicalTrials.gov ID
- NCT01317407
- Acronym / sponsor ID
- VIPSafe / SKKarlsruhe-VIPSafe
- Conditions
- Postoperative Confusion
- Keywords
- postoperative delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Staedtisches Klinikum KarlsruheUniversity, hospital or other
- Collaborators
- Karlsruhe Institute of Technology
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a planned or not-planned stay at the intensive care unit after an operation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- absent written consent
- age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Confusion, run by Staedtisches Klinikum Karlsruhe at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franz Kehl, Professor Dr. med. (++49-721-974-1601, franz.kehl@klinikum-karlsruhe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.