CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
central venous catheter positioning in right atriumprocedure
Likely dose
Not stated in record
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Search/NCT01398436
NCT01398436N/ACompleted

Comparison Between Hemoglobin Saturation in the Superior Vena Cava and in the Right Atrium

Catholic University of the Sacred Heart·interventional·Posted Jul 20, 2011·Updated Apr 22, 2013

In Brief

A clinical study evaluating central venous catheter positioning in right atrium for Cardiac Surgery and Shock. Completed, enrolled 61 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.0 years ago

Interventions

central venous catheter positioning in right atriumprocedure

A central venous catheter will be advanced for its entire length unless arrhythmias develop. Catheter position will be controlled by transesophageal echocardiography and/or by chest radiography