Cardiac SurgeryNCT01398436
Hemoglobin Saturation in Superior Vena Cava and Right Atrium
A study testing central venous catheter positioning in right atrium in people with Cardiac Surgery and Shock, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Shock
- What is being tested?
- central venous catheter positioning in right atrium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli"
Rome, 00168
About this study
Official title: Comparison Between Hemoglobin Saturation in the Superior Vena Cava and in the Right Atrium
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.
- The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens:
- a Bland Altman analysis between proximal and distal oxygen saturation in group A, in order to evaluate if the two measures are equivalent
- a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors
- In addition:
- 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
- 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
- The secondary aim of the study will be achieved by comparing the incidence of cardiac arrhythmias in groups A and C
Read the 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.
- Conditions
- Cardiac Surgery, Shock
- Being tested
- central venous catheter positioning in right atrium
- Keywords
- Central venous saturation, Mixed venous saturation, Right atrium, Central Venous Catheter position
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheter positioning in right atriumProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 hours
Secondary outcomes (1)
Safety of central venous catheters with the tip in the right atrium in ICU patients
To evaluate the incidence of arrhythmic and traumatic complications in the study group and in controls
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Cavaliere, Catholic University of the Sacred Heart
- Investigators
- Franco Cavaliere, Professor, Principal investigator, Catholic University of Sacred Heart, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398436
- Sponsor's protocol ID
- P/999/CE/2010
- Status last verified
- Apr 2013
- First submitted
- 19 Jul 2011
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16052106Edwards 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.
PubMed 9710094Chawla 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.
PubMed 15596689Pikwer 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.
PubMed 18326129Webster 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.
PubMed 12635401Cavaliere 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.
PubMed 23857438
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Hemoglobin Saturation in the Superior Vena Cava and in the Right Atrium
- ClinicalTrials.gov ID
- NCT01398436
- Acronym / sponsor ID
- P/999/CE/2010
- Conditions
- Cardiac Surgery, Shock
- Keywords
- Central venous saturation, Mixed venous saturation, Right atrium, Central Venous Catheter position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens:
- a Bland Altman analysis between proximal and distal oxygen saturation in group A, in order to evaluate if the two measures are equivalent
- a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors
- In addition:
- 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
- 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
- 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 "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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter tip in right atrium | Experimental | Procedure: central venous catheter positioning in right atriumIn 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| central venous catheter positioning in right atriumA 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 or surgery | Catheter tip in right atrium |
Primary outcome
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
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
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
1 secondary outcome
Safety of central venous catheters with the tip in the right atrium in ICU patients
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Background: PubMed 16052106Dueck 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.
- Background: PubMed 9710094Edwards 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.
- Background: PubMed 15596689Chawla 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.
- Background: PubMed 18326129Pikwer 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.
- Background: PubMed 12635401Webster 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.
- Derived from this study: PubMed 23857438Cavaliere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Cavaliere, Professor principal investigator
Catholic University of Sacred Heart, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central venous catheter positioning in right atrium in people with Cardiac Surgery and Shock, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398436, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.