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OpenTrials
Completed

NCT Number: NCT03834675

Suitability of PICC for Transpulmonary Thermodilution Compared to CICC

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 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

transpulmonary thermodilution

Diagnostic Test

Thermodilution was attempted via PICC and via CICC

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 4Fr PICCs to CICC

    Time frame: one hour

    Comparison of single-lumen 4 Fr PICCs to CICC in their reliability of assessing cardiac output

  2. Comparison 5Fr PICCs to CICC

    Time frame: one hour

    Comparison of dual-lumen 5 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
  • Maria Giuseppina Annetta
  • Massimo Antonelli
  • Mauro Pittiruti
  • Sofia Cacciola

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Jan 27, 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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