Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632197
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPNO-SVO2
Brief Summary:
The objective of this study is to compare the accuracy and correlation of the capnodynamic method for measuring mixed venous oxygen saturation SvO2 with the standard reference method pulmonary artery catheter with the potential for the capnodynamic method to replace the traditional method in selected cases
Detailed Description:
The main objective is to evaluate the accuracy and correlation of mixed venous oxygen saturation SvO2 measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter PAC Swan-Ganz with the potential to replace it in selected cases in patients who would benefit from hemodynamic monitoring with PAC for their clinical management and decision-making
The investigator will also study the following secondary objectives
To assess whether the capnodynamic method Capno-SvO2 detects changes over time in the studied variable SvO2 showing good concordance and magnitude compared to the reference method
To evaluate the progression and trend of the Capno-SvO2 method in different clinical situations such as in adult respiratory distress syndrome and patients with other respiratory pathologies as well as patients with cardiac conditions
To assess the ability of the Capno-SvO2 method to detect changes in mixed venous oxygen saturation in response to therapeutic interventions eg adjustments in mechanical ventilation use of inotropes vasopressors or fluid therapy or moderate hemodynamic changes
To evaluate the correlation between mixed venous oxygen saturation measured using the Capno-SvO2 method and other hemodynamic parameters such as cardiac output central venous pressure and cardiac index
The investigator will also study the following secondary objectives
To assess whether the capnodynamic method Capno-SvO2 detects changes over time in the studied variable SvO2 showing good concordance and magnitude compared to the reference method
To evaluate the progression and trend of the Capno-SvO2 method in different clinical situations such as in adult respiratory distress syndrome and patients with other respiratory pathologies as well as patients with cardiac conditions
To assess the ability of the Capno-SvO2 method to detect changes in mixed venous oxygen saturation in response to therapeutic interventions eg adjustments in mechanical ventilation use of inotropes vasopressors or fluid therapy or moderate hemodynamic changes
To evaluate the correlation between mixed venous oxygen saturation measured using the Capno-SvO2 method and other hemodynamic parameters such as cardiac output central venous pressure and cardiac index
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