NCT01712750

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

First QC Date

October 23, 2012

Last Update Submit

October 25, 2012

Conditions

Vascular Occlusion Test

Keywords

Regional tissue oximetryCardiopulmonary bypassCardiac surgical procedures

Outcome Measures

Primary Outcomes (1)

  • VOT reperfusion slope

    Reperfusion slope as measured during vascular occlusion test in units of %/s

    Intra-operative (within 12 hours)

Study Arms (1)

VOT on bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective cardiac surgery patients undergoing coronary artery bypass and valve surgery using cardiopulmonary bypass.

You may qualify if:

  • Adult, elective cardiac surgery patients
  • Procedure using cardiopulmonary bypass

You may not qualify if:

  • Contraindication to pneumatic cuff inflation
  • Pregnant
  • Significant peripheral vascular disease of the arms
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Study Officials

  • John M Murkin, MD, FRCPC

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 24, 2012

Study Start

February 1, 2011

Study Completion

September 1, 2011

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

CA(1)