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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:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01712750
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • VOT reperfusion slope [ Time Frame: Intra-operative (within 12 hours) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01712750     History of Changes
Other Study ID Numbers: REB-17456
Study First Received: October 23, 2012
Last Updated: October 25, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013