Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431535
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2007-02-05
Brief Title:
Study Concerning Relationship Between Mixed Venous Saturation SvO2 and Balance
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
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 mobilizationThis 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-operativelyone 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 mobilizationThis 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-operativelyone 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None