- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712750
Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients
October 25, 2012 updated by: London Health Sciences Centre
Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a non-invasive near infrared spectrometry (NIRS) machine.
The purpose of this study is to determine whether changes in VOT measurements occur in patients during cardiac surgery.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
-
London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elective cardiac surgery patients undergoing coronary artery bypass and valve surgery using cardiopulmonary bypass.
Description
Inclusion Criteria:
- Adult, elective cardiac surgery patients
- Procedure using cardiopulmonary bypass
Exclusion Criteria:
- Contraindication to pneumatic cuff inflation
- Pregnant
- Significant peripheral vascular disease of the arms
- Emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
VOT on bypass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VOT reperfusion slope
Time Frame: Intra-operative (within 12 hours)
|
Reperfusion slope as measured during vascular occlusion test in units of %/s
|
Intra-operative (within 12 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John M Murkin, MD, FRCPC, London Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
October 23, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (ESTIMATE)
October 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 26, 2012
Last Update Submitted That Met QC Criteria
October 25, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- REB-17456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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