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

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

    • 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.

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

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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