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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01712750
Other study ID # REB-17456
Secondary ID
Status Completed
Phase N/A
First received October 23, 2012
Last updated October 25, 2012
Start date February 2011
Est. completion date September 2011

Study information

Verified date October 2012
Source London Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date September 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada London Health Sciences Centre London Ontario

Sponsors (1)

Lead Sponsor Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary VOT reperfusion slope Reperfusion slope as measured during vascular occlusion test in units of %/s Intra-operative (within 12 hours) No