AneurysmNCT01094938
Cardiac Output Monitoring in Aortic Aneurysm Surgery
An observational study of Aneurysm, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Jul 2008
- 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: Edinburgh based trial in aortic aneurysm repair
Who may be able to join
- Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair
Who cannot join
- Patients not giving informed consent.
- Patients under the age of 18 years.
- Patients who may be pregnant
- Patients with learning disabilities.
- Rhythm other than sinus rhythm.
- Patients on oral lithium therapy.
- Patients less than 40kg
- Patients with severe mitral regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.
- Conditions
- Aneurysm
- Keywords
- Aortic aneurysm repair
- Medical subject headings
- Aneurysm
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 |
|---|---|---|
| Repair | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Secondary outcomes (1)
Arterial Pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094938
- Sponsor's protocol ID
- EDICOAAS
- Other IDs
- 07/S1102/30
- Status last verified
- Mar 2010
- First submitted
- 26 Mar 2010
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Monitoring in Aortic Aneurysm Surgery
- ClinicalTrials.gov ID
- NCT01094938
- Acronym / sponsor ID
- EDICOAAS
- Conditions
- Aneurysm
- Keywords
- Aortic aneurysm repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Jul 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Mar 2010 (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.
To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repair | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Edinburgh based trial in aortic aneurysm repair
Key inclusion criteria (1 listed)
- Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair
Key exclusion criteria (8 listed)
- Patients not giving informed consent.
- Patients under the age of 18 years.
- Patients who may be pregnant
- Patients with learning disabilities.
- Rhythm other than sinus rhythm.
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
Cardiac output
1 secondary outcome
Arterial Pressure
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 23 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneurysm, run by NHS Lothian at 1 site in United Kingdom.
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 23 Sep 2024. 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 United Kingdom. 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.
What does the primary outcome measure?
Cardiac output. It is what the study was designed to measure, not a finding.
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 23 Sep 2024.