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

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ClinicalTrials.gov Identifier: NCT04241926
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Antonio Maria Dell Anna
Sofia Cacciola
Claudio Sandroni
Giulia Chiuri
Mauro Pittiruti
Cesare Colosimo
Maria Giuseppina Annetta
Massimo Antonelli
Information provided by (Responsible Party):
Dr.ssa Sonia D'Arrigo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Condition or disease Intervention/treatment Phase
Peripherally Inserted Central Catheters Centrally Inserted Central Catheter Transpulmonary Thermodilution Hemodynamic Monitoring Diagnostic Test: transpolmonary thermodilution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : February 9, 2020
Estimated Study Completion Date : February 29, 2020

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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Comparison of single-lumen 5Fr PICCs to CICC [ Time Frame: one hour ]
    Comparison of single-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output

  2. Comparison of triple-lumen 6Fr PICCs to CICC [ Time Frame: one hour ]
    Comparison of triple-lumen 6 Fr PICCs to CICC in their reliability of assessing cardiac output



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241926


Contacts
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Contact: Sonia D'Arrigo, MD +390630154490 sonia.darrigo@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Rome, Italia, Italy, 00168
Contact: Sonia D'Arrigo, MD    +390630154490    sonia.darrigo@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Antonio Maria Dell Anna
Sofia Cacciola
Claudio Sandroni
Giulia Chiuri
Mauro Pittiruti
Cesare Colosimo
Maria Giuseppina Annetta
Massimo Antonelli
Investigators
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Study Chair: Massimo Antonelli, MD Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
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Responsible Party: Dr.ssa Sonia D'Arrigo, Medical Doctor - PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04241926    
Other Study ID Numbers: PICC 5Fr and 6Fr-CICC for TPTD
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.ssa Sonia D'Arrigo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
PICC
CICC
Cardiac output
shock