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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04241926
Other study ID # PICC 5Fr and 6Fr-CICC for TPTD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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