Ignite Creation Date:
2024-05-05 @ 11:42 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01398436
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2011-07-19
Brief Title:
Hemoglobin Saturation in Superior Vena Cava and Right Atrium
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Comparison Between Hemoglobin Saturation in the Superior Vena Cava and in the Right Atrium
Status:
COMPLETED
Status Verified Date:
2013-04
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:
The aim of the study is to compare oxygen saturation of blood samples collected from the superior vena cava the right atrium and the pulmonary artery A secondary target was to assess whether positioning the tip of central venous catheters in the right atrium causes more arrhythmias than positioning it in the superior vena cava
The study is carried out in patients that undergo central venous and pulmonary artery catheterization for surgical coronary revascularization In the interventional group atrium A the tip of the central venous catheter CVC is placed in the right atrium in the control group control C the tip is placed in the superior vena cava In both groups CVC position is confirmed with transesophageal echocardiography TEE At fixed times during surgery and in the following 72 hours heparinized blood samples are collected from the proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter PC and oxygen saturation is measured by an oximeter Besides mechanical and electrical complications potentially influenced by CVC position are registered
1 The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens
1 a Bland Altman analysis between proximal and distal oxygen saturation in group A in order to evaluate if the two measures are equivalent
2 a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors
2 In addition
1 differences in oxygen saturation between proximal or distal CVC and distal PC will be compared in order to evaluate whether distal saturation is more indicative of mixed venous saturation
2 differences between proximal and distal oxygen saturation will be correlated with cardiac index and PCWP to investigate if low cardiac output and hypovolemia increase differences
3 The secondary aim of the study will be achieved by comparing the incidence of cardiac arrhythmias in groups A and C
The study is carried out in patients that undergo central venous and pulmonary artery catheterization for surgical coronary revascularization In the interventional group atrium A the tip of the central venous catheter CVC is placed in the right atrium in the control group control C the tip is placed in the superior vena cava In both groups CVC position is confirmed with transesophageal echocardiography TEE At fixed times during surgery and in the following 72 hours heparinized blood samples are collected from the proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter PC and oxygen saturation is measured by an oximeter Besides mechanical and electrical complications potentially influenced by CVC position are registered
1 The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens
1 a Bland Altman analysis between proximal and distal oxygen saturation in group A in order to evaluate if the two measures are equivalent
2 a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors
2 In addition
1 differences in oxygen saturation between proximal or distal CVC and distal PC will be compared in order to evaluate whether distal saturation is more indicative of mixed venous saturation
2 differences between proximal and distal oxygen saturation will be correlated with cardiac index and PCWP to investigate if low cardiac output and hypovolemia increase differences
3 The secondary aim of the study will be achieved by comparing the incidence of cardiac arrhythmias in groups A and C
Detailed Description:
The study design is a prospective randomized open-label study Forty consecutive patients undergoing cardiac surgery requiring the placement of a central venous catheter and of a Swan-Ganz catheter and then admitted to Cardiac Surgery ICU of AGemelli University Hospital will be included in the study Patients will be randomized to two groups A group in which the catheter tip will be positioned in right atrium and C control group in which the catheter tip will be positioned in the superior vena cava at the junction with the atrium
Arrow catheters 3 lumen 85 Fr 20 cm long will be used Catheters will be placed in right internal jugular or subclavian vein with Seldinger technique In group A the catheter will be advanced for its entire length unless arrhythmias develop in group C the catheter will be inserted for 15 cm Catheter position will be controlled by transesophageal echocardiography andor by chest radiography In order to avoid risk of damage to the atrial wall ECG and central venous pressure will be monitored during the entire observation period and the catheter will be repositioned withdrawing it in presence of extrasystoles or other arrhythmias potentially triggered by contact between the catheter tip and the heart wall in case of flattening of the curve of the central venous pressure caused by contact with the atrial wall or in presence of a ventricular type of curve migration of the catheter in the right ventricle through the tricuspid valve The catheter tip will be removed or repositioned in superior vena cava at the time of mobilization of the patient or of his transfer to another unit
A sample of arterial blood from an arterial line one of mixed venous blood from the pulmonary catheter and two samples from the CVC one from the distal lumen and a proximal lumen will be taken at different times time 1 at CVC placement time 2 after sternotomy time 3 after after discontinuation of CBP time 4 at admission to ICU time 5 67 8 respectively 6 18 30 and 42 hours after the end of surgery Samples volume of 1 mL will be collected in heparinized syringes and immediately analyzed by a stat analyzer Stat Profile Critical Care Xpress by Nova Biomedical with integrated on-board CO-Oximetry allowing direct measurement of oxygen saturation
The values of pH pO2 pCO2 and saturation of venous samples will be compared and the difference will be analyzed by Bland-Altman method The observed difference will also be correlated with indexes of tissue perfusion arterial base excess arterial plasma lactate and with the presence and dose of vasoactive drugs infusion
Arrow catheters 3 lumen 85 Fr 20 cm long will be used Catheters will be placed in right internal jugular or subclavian vein with Seldinger technique In group A the catheter will be advanced for its entire length unless arrhythmias develop in group C the catheter will be inserted for 15 cm Catheter position will be controlled by transesophageal echocardiography andor by chest radiography In order to avoid risk of damage to the atrial wall ECG and central venous pressure will be monitored during the entire observation period and the catheter will be repositioned withdrawing it in presence of extrasystoles or other arrhythmias potentially triggered by contact between the catheter tip and the heart wall in case of flattening of the curve of the central venous pressure caused by contact with the atrial wall or in presence of a ventricular type of curve migration of the catheter in the right ventricle through the tricuspid valve The catheter tip will be removed or repositioned in superior vena cava at the time of mobilization of the patient or of his transfer to another unit
A sample of arterial blood from an arterial line one of mixed venous blood from the pulmonary catheter and two samples from the CVC one from the distal lumen and a proximal lumen will be taken at different times time 1 at CVC placement time 2 after sternotomy time 3 after after discontinuation of CBP time 4 at admission to ICU time 5 67 8 respectively 6 18 30 and 42 hours after the end of surgery Samples volume of 1 mL will be collected in heparinized syringes and immediately analyzed by a stat analyzer Stat Profile Critical Care Xpress by Nova Biomedical with integrated on-board CO-Oximetry allowing direct measurement of oxygen saturation
The values of pH pO2 pCO2 and saturation of venous samples will be compared and the difference will be analyzed by Bland-Altman method The observed difference will also be correlated with indexes of tissue perfusion arterial base excess arterial plasma lactate and with the presence and dose of vasoactive drugs infusion
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