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Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712750
First Posted: October 24, 2012
Last Update Posted: October 26, 2012
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.
Information provided by:
London Health Sciences Centre
  Purpose
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.

Condition
Vascular Occlusion Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • VOT reperfusion slope [ Time Frame: Intra-operative (within 12 hours) ]
    Reperfusion slope as measured during vascular occlusion test in units of %/s


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: September 2011
Groups/Cohorts
VOT on bypass

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective cardiac surgery patients undergoing coronary artery bypass and valve surgery using cardiopulmonary bypass.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712750


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: John M Murkin, MD, FRCPC London Health Sciences Centre
  More Information

ClinicalTrials.gov Identifier: NCT01712750     History of Changes
Other Study ID Numbers: REB-17456
First Submitted: October 23, 2012
First Posted: October 24, 2012
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by London Health Sciences Centre:
Regional tissue oximetry
Cardiopulmonary bypass
Cardiac surgical procedures