- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834675
Suitability of PICC for Transpulmonary Thermodilution Compared to CICC
January 22, 2020 updated by: Dr.ssa Sonia D'Arrigo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Are Peripherally Inserted Central Catheters (PICC) Suitable for Cardiac Output Assessment With Trans-pulmonary 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 we try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one hour
|
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
|
one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
January 31, 2019
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (ACTUAL)
February 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PICC -CICC for TPTD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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