Suitability of PICC for Transpulmonary Thermodilution Compared to CICC
Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary Thermodilution
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 8, 2019
CompletedJanuary 27, 2020
February 1, 2019
7 months
February 5, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparison 4Fr PICCs to CICC
one hour
Comparison 5Fr PICCs to CICC
one hour
Interventions
Thermodilution was attempted via PICC and via CICC
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSlead
- Claudio Sandronicollaborator
- Sofia Cacciolacollaborator
- Antonio Maria Dell Annacollaborator
- Mauro Pittiruticollaborator
- Maria Giuseppina Annettacollaborator
- Cesare Colosimocollaborator
- Massimo Antonellicollaborator
Study Sites (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Related Publications (1)
D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are Peripherally Inserted Central Catheters Suitable for Cardiac Output Assessment With Transpulmonary Thermodilution? Crit Care Med. 2019 Oct;47(10):1356-1361. doi: 10.1097/CCM.0000000000003917.
PMID: 31356470DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Massimo Antonelli, MD
Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor - PhD
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 8, 2019
Study Start
June 1, 2018
Primary Completion
December 31, 2018
Study Completion
January 31, 2019
Last Updated
January 27, 2020
Record last verified: 2019-02