Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-29 @ 6:01 PM
Study NCT ID:
NCT00431535
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.
Detailed Description:
It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.
Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.
We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.
This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.
The tests will consist of:
1. 10 min of rest.
2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.
Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.
Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.
At the same time the patient will be pain-scored when taking a new position.
Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.
We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.
This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.
The tests will consist of:
1. 10 min of rest.
2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.
Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.
Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.
At the same time the patient will be pain-scored when taking a new position.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: