Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate... | NCT04241926

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

NCT04241926

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

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

Interventions

transpolmonary thermodilution

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Feb 9, 2020Actual

Completion Date

Feb 29, 2020Actual

First Submitted Date

Jan 22, 2020

First Submission Date that Met QC Criteria

Jan 22, 2020

First Posted Date

Jan 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr.ssa Sonia D'Arrigo, Medical Doctor - PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Name	Class
Antonio Maria Dell Anna	UNKNOWN
Sofia Cacciola	UNKNOWN
Claudio Sandroni	UNKNOWN
Giulia Chiuri

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transpolmonary thermodilution	Diagnostic Test	Thermodilution was attempted via PICC and via CICC in the same patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Massimo Antonelli, MD	Università Cattolica del sacro Cuore- Fondazione Policlinico Universitario A. Gemelli IRCSS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A. Gemelli IRCCS		Rome	Italia	00168	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33284392	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms