Value of Virtual Autopsy for Quality Control in IcuNCT01541982
Virtual Autopsy for Quality Control on Intensive Care Medicine
An observational study of Value of Virtual Autopsy for Quality Control in Icu, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial summary
The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Value of Virtual Autopsy for Quality Control in Icu
- How many people
- 160 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Jul 2013
- 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 dying in the icu
Who may be able to join
- age >18
- all patients dying in the icu during the study period
Who cannot join
- relatives refuse participation in the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
About this study
The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine.
Read the detailed description
The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine. Especially with respect to complications during intervention like catheter pacement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| virtual and classic autopsy | "Goldstandard": A group of patients in which virtual and classic autopsy is performed. | |
| virtual autopsy only | "Intervention": A group of patients in which for various reasons virtual autopsy only is performed. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Value of Virtual Autopsy for Quality Control in IcuStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Wichmann, MD, Principal investigator, Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541982
- Sponsor's protocol ID
- VA-2 Quality Control
- Status last verified
- Jun 2015
- First submitted
- 24 Feb 2012
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wichmann D, Heinemann A, Zahler S, Vogel H, Hopker W, Puschel K, Kluge S. Prospective study of device-related complications in intensive care unit detected by virtual autopsy. Br J Anaesth. 2018 Jun;120(6):1229-1236. doi: 10.1016/j.bja.2018.02.031. Epub 2018 Apr 4.
PubMed 29793590
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Autopsy for Quality Control on Intensive Care Medicine
- ClinicalTrials.gov ID
- NCT01541982
- Acronym / sponsor ID
- VA-2 Quality Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Mar 2012 (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.
The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine.
Detailed description
The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine. Especially with respect to complications during intervention like catheter pacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual and classic autopsy | – | –"Goldstandard": A group of patients in which virtual and classic autopsy is performed. |
| virtual autopsy only | – | –"Intervention": A group of patients in which for various reasons virtual autopsy only is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients dying in the icu
Key inclusion criteria (2 listed)
- age >18
- all patients dying in the icu during the study period
Key exclusion criteria (1 listed)
- relatives refuse participation in the study
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
- Derived from this study: PubMed 29793590Wichmann D, Heinemann A, Zahler S, Vogel H, Hopker W, Puschel K, Kluge S. Prospective study of device-related complications in intensive care unit detected by virtual autopsy. Br J Anaesth. 2018 Jun;120(6):1229-1236. doi: 10.1016/j.bja.2018.02.031. Epub 2018 Apr 4.
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.
Dominic Wichmann, MD principal investigator
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Value of Virtual Autopsy for Quality Control in Icu, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01541982, which also lists 1 linked publication.
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 Jun 2015.