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

NCT04241926 | Completed

• 1 other identifier: PICC 5Fr and 6Fr-CICC for TPTD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 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 the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.

Conditions

Peripherally Inserted Central Catheters; Centrally Inserted Central Catheter; Transpulmonary Thermodilution; Hemodynamic Monitoring

Keywords

PICC; CICC; Cardiac output; shock

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 of single-lumen 5Fr PICCs to CICC

  one hour

• Comparison of triple-lumen 6Fr PICCs to CICC

  one hour

Interventions

transpolmonary thermodilution DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Antonio Maria Dell Anna: collaborator
• Sofia Cacciola: collaborator
• Claudio Sandroni: collaborator
• Giulia Chiuri: collaborator
• Mauro Pittiruti: collaborator
• Cesare Colosimo: collaborator
• Maria Giuseppina Annetta: collaborator
• Massimo Antonelli: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italia, 00168, Italy

Location

Related Publications (1)

• D'Arrigo S, Sandroni C, Cacciola S, Dell'Anna AM, Pittiruti M, Annetta MG, Colosimo C, Antonelli M. Are single-lumen 5Fr and triple-lumen 6Fr PICCs suitable for hemodynamic assessment by trans-pulmonary thermodilution? A pilot study. Ann Intensive Care. 2020 Dec 7;10(1):165. doi: 10.1186/s13613-020-00785-2.

  PMID: 33284392 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Antonelli, MD

  Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS

  STUDY CHAIR

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: January 22, 2020
• First Posted: January 27, 2020
• Study Start: May 1, 2019
• Primary Completion: February 9, 2020
• Study Completion: February 29, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)