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Completed

NCT Number: NCT04241926

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

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.

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Key information

Conditions

Peripherally Inserted Central Catheters Centrally Inserted Central Catheter Hemodynamic Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Transpulmonary Thermodilution

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italia, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transpolmonary thermodilution

Diagnostic Test

Thermodilution was attempted via PICC and via CICC in the same patient

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Antonio Maria Dell Anna
  • Cesare Colosimo
  • Claudio Sandroni
  • Giulia Chiuri
  • Maria Giuseppina Annetta
  • Massimo Antonelli
  • Mauro Pittiruti
  • Sofia Cacciola

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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