Suitability of PICC for Transpulmonary Thermodilution Compared to CICC

Hemodynamic Monitoring Clinical Trial

Official title:

Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834675
• Other study ID #: PICC -CICC for TPTD
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (=18 years) admitted to the ICU

• Patients requiring hemodynamic monitoring using EV1000TM

• Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

Exclusion Criteria:

• body weight <40 kg

• severe aortic regurgitation or intra-cardiac shunt

• treatment with an intra-aortic balloon pump

• contraindication for placement of PICC, CICC or a femoral arterial catheter

• abdominal aneurism

• extracorporeal circulation

• pregnancy

• lack of informed consent

Related Conditions & MeSH terms

• CVC
• Hemodynamic Monitoring
• Peripherally Inserted Central Catheters
• Transpulmonary Thermodilution

Intervention

Diagnostic Test:
• transpulmonary thermodilution
Thermodilution was attempted via PICC and via CICC

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (8)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Antonio Maria Dell Anna, Cesare Colosimo, Claudio Sandroni, Maria Giuseppina Annetta, Massimo Antonelli, Mauro Pittiruti, Sofia Cacciola

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Index comparison via PICC	comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.	One hour
Secondary	Comparison 4Fr PICCs to CICC	Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output	one hour
Secondary	Comparison 5Fr PICCs to CICC	Comparison of dual-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output	one hour