Hemoglobin Saturation in Superior Vena Cava and Right Atrium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Franco Cavaliere, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01398436
First received: July 19, 2011
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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

Condition Intervention
Cardiac Surgery
Shock
Procedure: central venous catheter positioning in right atrium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison Between Hemoglobin Saturation in the Superior Vena Cava and in the Right Atrium

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Difference between oxygen saturation in blood collected from the proximal and distal lumens of a central venous catheter the tip of which is positioned in the right atrium [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Large differences from the proximal and distal lumens means that blood from the superior vena cava is poorly representative of blood from the inferior vena cava and the coronary sinus

  • Difference between oxygen saturation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Difference between oxygen saturation in blood collected from the proximal and distal lumens of a central venous catheter the tip of which is positioned in the right atrium and oxygen saturation in pulmonary artery


Secondary Outcome Measures:
  • Safety of central venous catheters with the tip in the right atrium in ICU patients [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    To evaluate the incidence of arrhythmic and traumatic complications in the study group and in controls


Enrollment: 61
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter tip in right atrium
In this group 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.
Procedure: central venous catheter positioning in right atrium
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
No Intervention: Catheter tip in superior vena cava
In this group a central venous catheter will be inserted for 15 cm in accordance with standard practice. Catheter position will be controlled by transesophageal echocardiography and/or by chest radiography

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 "A.Gemelli" 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, 8,5 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 and/or 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, 6,7 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing cardiac surgery requiring the placement of a central venous catheter and of a pulmonary artery catheter, and then admitted to Cardiac Surgery ICU

Exclusion Criteria:

  • age less than 18 years,
  • contraindication to catheterization through the right internal jugular or right subclavian vein
  • presence of inflammatory disease of the heart (eg myocarditis) or any other disease increasing the risk of complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398436

Locations
Italy
Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Franco Cavaliere, Professor Catholic University of Sacred Heart, Rome
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franco Cavaliere, Associate Professor of Anaesthesia and Intensive Care, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01398436     History of Changes
Other Study ID Numbers: P/999/CE/2010
Study First Received: July 19, 2011
Last Updated: April 19, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
Central venous saturation
Mixed venous saturation
Right atrium
Central Venous Catheter position

ClinicalTrials.gov processed this record on October 22, 2014