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Study of Post-operative Oxygen Consumption Following Vascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01327820
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

Tracking Information
First Submitted Date March 31, 2011
First Posted Date April 4, 2011
Last Update Posted Date March 24, 2016
Study Start Date March 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2011)
Whole body oxygen consumption [ Time Frame: post-operative day 1 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01327820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Post-operative Oxygen Consumption Following Vascular Surgery
Official Title Study of Post-operative Oxygen Consumption Following Vascular Surgery
Brief 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
Condition
  • Oxygen Consumption
  • Aortic Aneurysm
  • Peripheral Arterial Disease
Intervention Not Provided
Study Groups/Cohorts
  • Open aortic aneurysm repair
  • Endovascular aortic aneurysm repair
  • Infra-inguinal lower limb revascularisation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2016)
27
Original Estimated Enrollment
 (submitted: April 1, 2011)
69
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh

Exclusion Criteria:

  • Patient refusal
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01327820
Other Study ID Numbers 2011/R/AN/01
11/S1102/1 ( Other Identifier: South East Scotland Research Ethics Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NHS Lothian
Study Sponsor NHS Lothian
Collaborators Not Provided
Investigators Not Provided
PRS Account NHS Lothian
Verification Date March 2011