Hemoglobin Saturation in Superior Vena Cava and Right Atrium

NCT01398436 | Completed

• 1 other identifier: P/999/CE/2010
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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. 1.The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens:
2. 2.a Bland Altman analysis between proximal and distal oxygen saturation in group A, in order to evaluate if the two measures are equivalent
3. 3.a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors
4. 4.In addition:
5. 5.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
6. 6.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
7. 7.The secondary aim of the study will be achieved by comparing the incidence of cardiac arrhythmias in groups A and C

Conditions

Cardiac Surgery; Shock

Keywords

Central venous saturation; Mixed venous saturation; Right atrium; Central Venous Catheter position

Outcome Measures

Primary Outcomes (2)

• 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

  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

  72 hours

• Difference between oxygen saturation

  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

  72 hours

Secondary Outcomes (1)

• Safety of central venous catheters with the tip in the right atrium in ICU patients

  72 hours

Study Arms (2)

Catheter tip in right atrium

EXPERIMENTAL

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

Catheter tip in superior vena cava

NO INTERVENTION

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

Interventions

central venous catheter positioning in right atrium PROCEDURE

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

Catheter tip in right atrium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"

Rome, 00168, Italy

Location

Related Publications (6)

• Dueck MH, Klimek M, Appenrodt S, Weigand C, Boerner U. Trends but not individual values of central venous oxygen saturation agree with mixed venous oxygen saturation during varying hemodynamic conditions. Anesthesiology. 2005 Aug;103(2):249-57. doi: 10.1097/00000542-200508000-00007.

  PMID: 16052106 BACKGROUND

• Edwards JD, Mayall RM. Importance of the sampling site for measurement of mixed venous oxygen saturation in shock. Crit Care Med. 1998 Aug;26(8):1356-60. doi: 10.1097/00003246-199808000-00020.

  PMID: 9710094 BACKGROUND

• Chawla LS, Zia H, Gutierrez G, Katz NM, Seneff MG, Shah M. Lack of equivalence between central and mixed venous oxygen saturation. Chest. 2004 Dec;126(6):1891-6. doi: 10.1378/chest.126.6.1891.

  PMID: 15596689 BACKGROUND

• Pikwer A, Baath L, Davidson B, Perstoft I, Akeson J. The incidence and risk of central venous catheter malpositioning: a prospective cohort study in 1619 patients. Anaesth Intensive Care. 2008 Jan;36(1):30-7. doi: 10.1177/0310057X0803600106.

  PMID: 18326129 BACKGROUND

• Webster CS, Merry AF, Emmens DJ, Van Cotthem IC, Holland RL. A prospective clinical audit of central venous catheter use and complications in 1000 consecutive patients. Anaesth Intensive Care. 2003 Feb;31(1):80-6. doi: 10.1177/0310057X0303100116.

  PMID: 12635401 BACKGROUND

• Cavaliere F, Zamparelli R, Martinelli L, Scapigliati A, De Paulis S, Caricato A, Gargaruti R, Cina A. Blood from the right atrium may provide closer estimates of mixed venous saturation than blood from the superior vena cava. A pilot study. Minerva Anestesiol. 2014 Jan;80(1):11-8. Epub 2013 Jul 15.

  PMID: 23857438 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Franco Cavaliere, Professor

  Catholic University of Sacred Heart, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia and Intensive Care

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

IT (1)