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Clinical Trials/NCT03834675
NCT03834675CompletedNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 sites in 1 country20 target enrollmentStarted: June 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Cardiac Index comparison via PICC

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cardiac Index comparison via PICC

Time Frame: One hour

comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.

Secondary Outcomes

  • Comparison 4Fr PICCs to CICC(one hour)
  • Comparison 5Fr PICCs to CICC(one hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr.ssa Sonia D'Arrigo

Medical Doctor - PhD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Sites (2)

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