SurgeryNCT00431535
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance
An observational study of Surgery, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Surgery
- How many people
- 17 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2007to May 2007
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients going through Radical Prostatectomy, where CVC is standard.
Who cannot join
- Non informed consent
- ASA > II
- Age less than 18, or more than 80 years
- Diabetes Mellitus
- Epidural analgetics
- Alcohol abuse (investigators assessment)
- Unable to understand written or spoken information
- Using beta-blockers
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, Region Sjælland, 2200
Rigshospitalet
Copenhagen, Region Sjælland, 2200
About this study
Official title: Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively
It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.
Read the detailed description
It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.
Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.
We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.
This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.
The tests will consist of:
- 10 min of rest.
- 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.
Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.
Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.
At the same time the patient will be pain-scored when taking a new position.
- Conditions
- Surgery
- Keywords
- Fluid, SvO2, Mobilisation, Orthostatic function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Christoffer Joergensen, M.S., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431535
- Sponsor's protocol ID
- SvO2
- Status last verified
- Oct 2007
- First submitted
- 5 Feb 2007
- Last updated
- 17 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively
- ClinicalTrials.gov ID
- NCT00431535
- Acronym / sponsor ID
- SvO2
- Conditions
- Surgery
- Keywords
- Fluid, SvO2, Mobilisation, Orthostatic function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- May 2007 (actual)
- First posted
- 6 Feb 2007 (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.
It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.
Detailed description
It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.
Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.
We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.
This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.
The tests will consist of:
- 10 min of rest.
- 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.
Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.
Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.
At the same time the patient will be pain-scored when taking a new position.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients going through Radical Prostatectomy, where CVC is standard.
Key exclusion criteria (8 listed)
- Non informed consent
- ASA > II
- Age less than 18, or more than 80 years
- Diabetes Mellitus
- Epidural analgetics
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 2013.
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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.
Christoffer Joergensen, M.S. principal investigator
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 Surgery, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 1 inclusion and 8 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 2013. 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 Denmark. 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?
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 2013.