Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.

Hemodynamic Monitoring Clinical Trial

Official title:

Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241926
• Other study ID #: PICC 5Fr and 6Fr-CICC for TPTD
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: July 2020
• 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 the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 29, 2020
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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

• Centrally Inserted Central Catheter
• Hemodynamic Monitoring
• Peripherally Inserted Central Catheters
• Transpulmonary Thermodilution

Intervention

Diagnostic Test:
• transpolmonary thermodilution
Thermodilution was attempted via PICC and via CICC in the same patient

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Antonio Maria Dell Anna, Cesare Colosimo, Claudio Sandroni, Giulia Chiuri, 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 of single-lumen 5Fr PICCs to CICC	Comparison of single-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output	one hour
Secondary	Comparison of triple-lumen 6Fr PICCs to CICC	Comparison of triple-lumen 6 Fr PICCs to CICC in their reliability of assessing cardiac output	one hour