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

Not Applicable

Completed

• Conditions: Centrally Inserted Central Catheter; Hemodynamic Monitoring; Peripherally Inserted Central Catheters; Transpulmonary Thermodilution

• Registration Number: NCT04241926
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cardiac Index comparison via PICC	one hour	comparison of hemodynamic measurements made by the TPTD from the VolumeView/EV1000TM system via PICC vs. CICC.

Secondary Outcome Measures

Name	Time	Method
Comparison of single-lumen 5Fr PICCs to CICC	one hour	Comparison of single-lumen 5 Fr PICCs to CICC in their reliability of assessing cardiac output
Comparison of triple-lumen 6Fr PICCs to CICC	one hour	Comparison of triple-lumen 6 Fr PICCs to CICC in their reliability of assessing cardiac output

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italia, Italy