Measurement of Cardiac Index Using an Implanted Central Venous Access Port in Patients Scheduled for Oncologic High-risk Surgery (ThermoD-PAC)

Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery

Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

Study Overview

• Status: Completed
• Conditions: Oncologic High-risk Surgery

Detailed Description

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. We conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Gustave Roussy Cancer Campus Grand Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients scheduled for oncologic high-risk surgery

Description

Inclusion Criteria:

• presence of port
• scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
• oral consent of the patient after oral and written information

Exclusion Criteria:

• age inferior to 18
• Contraindication or failure to the insertion of the CVC
• Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients scheduled for oncologic high-risk surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the reliability of the measurement of the variations of the CI during fluid challenge	Measurements will be realized as described: hourly: TPTD will be realized to calibrate the measurement of CI; Before and after fluid challenge (250 ml of colloid when hemodynamic indicators will be in favour of hypovolemia (pulse pressure variation (PPV) > 15% and variation of CI > 10%)	measurement of the CI hourly, up to 3 hours by TPTD before and after fluid challenge via the port versus the CVC.

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Principal Investigator: Alexandre Eghiaian, MD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

General Publications

• Suria S, Wyniecki A, Eghiaian A, Monnet X, Weil G. Measurement of cardiac index by transpulmonary thermodilution using an implanted central venous access port: a prospective study in patients scheduled for oncologic high-risk surgery. PLoS One. 2014 Aug 19;9(8):e104369. doi: 10.1371/journal.pone.0104369. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 13, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2011-A00003-40; 2012/1836 (Other Identifier: CSET number)