Oxygen ConsumptionNCT01327820
Study of Post-operative Oxygen Consumption Following Vascular Surgery
An observational study of Oxygen Consumption and Aortic Aneurysm, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oxygen Consumption, Aortic Aneurysm, Peripheral Arterial Disease
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
Who may be able to join
- Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).
- Keywords
- Oxygen consumption, Aortic Aneurysm, Peripheral Arterial Disease
- Medical subject headings
- Aortic Aneurysm, Peripheral Arterial Disease
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 |
|---|---|---|
| Open aortic aneurysm repair | Not described | |
| Endovascular aortic aneurysm repair | Not described | |
| Infra-inguinal lower limb revascularisation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body oxygen consumption
Measured: post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ConsumptionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327820
- Sponsor's protocol ID
- 2011/R/AN/01
- Other IDs
- 11/S1102/1
- Status last verified
- Mar 2011
- First submitted
- 31 Mar 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Post-operative Oxygen Consumption Following Vascular Surgery
- ClinicalTrials.gov ID
- NCT01327820
- Acronym / sponsor ID
- 2011/R/AN/01
- Keywords
- Oxygen consumption, Aortic Aneurysm, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Apr 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.
To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open aortic aneurysm repair | – | – |
| Endovascular aortic aneurysm repair | – | – |
| Infra-inguinal lower limb revascularisation | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
Key inclusion criteria (1 listed)
- Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
Key exclusion criteria (1 listed)
- Patient refusal
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
Whole body oxygen consumption
Time frame: post-operative day 1
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 24 Mar 2016.
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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 Oxygen Consumption and Aortic 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 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 24 Mar 2016. 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?
Whole body oxygen consumption (time frame: post-operative day 1). 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 24 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.