Comparison of Central Venous Pressures (CVPs) Measured From Peripherally Inserted Central Catheters (PICC) and CICC in Liver Transplantation Recipients (PICC)

October 1, 2009 updated by: National Cancer Center, Korea

Comparison of the Central Venous Pressures Measured From the Peripherally Inserted Antecubital Central Catheters and the Internal Jugular Vein Central Catheters in Liver Transplantation Recipients

Background: Central venous pressure (CVP) monitoring from the peripherally inserted central venous catheter (PICC) has not often been used because of the higher inherent resistance of the PICC due to its longer length and narrower lumen. The objective of this study was to assess the reliability of the CVP measured from PICCs as a predictor of the CVP measured from CICCs in the setting of rapidly fluctuating hemodynamic conditions during liver transplantation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to the protocol of LT in our hospital, a PICC is concomitantly inserted with the pulmonary artery catheter (PAC) and 9-Fr advanced venous access (AVA) catheter for the LT recipient at anesthetic induction. PAC and AVA catheter are usually removed on the second postoperative day, and instead the PICC is used for the postoperative infusion of prostaglandin E1 which is very irritable to small peripheral vein. So we fortunately had chance to measure the CVPs from both CICC and PICC simultaneously in the same patients.

Methods: We measured the CVPs from the CICC and the PICC simultaneously during each main surgical period of adult liver transplantation (preanhepatic, anhepatic, reperfusion, and neo-hepatic period). Data are presented as means ± standard deviation. Statistical analysis was performed using simple linear regression analysis to observe whether changes in the PICCP were paralleled by simultaneous changes in the CICCP. Bland-Altman analysis was used to determine the degree of agreement between the two devices. Analysis of variance was performed to study whether there were changes in the CVP agreement profiles in regard to the different time periods of LT. Differences were regarded as being statistically significant when p values were less than 0.05.

(This observational study has been completed already.)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

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

  • Korea, Republic of
    • Gyeonggi-do
      • 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients who had been scheduled for elective liver transplant surgery, and placed with both PICC and CICC.

Description

Inclusion Criteria:

  • Adult patients who had been scheduled for elective liver transplant surgery
  • Patients who had been placed with both PICC and CICC at anesthetic induction

Exclusion Criteria:

  • Failure to insert PICC

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Liver transplantation (LT) recipients
LT recipients who had both PICC and CICC at the same time according to the LT protocol of our hospital
Device: PICC, CICC
PICC insertion, CICC (advanced venous access with pulmonary artery catheter) insertion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
PICCP: CVP measured from peripherally inserted antecubital central catheters in liver transplantation recipients
Time Frame: every 10 minutes during the liver transplantation
every 10 minutes during the liver transplantation
CICCP: CVP from IJV central catheters in liver transplantation recipients
Time Frame: every 10 minutes during the liver transplantation
every 10 minutes during the liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Center, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: So-Hee Park, PhD, Department of cancer registration and biostatistics branch, Research institute and hospital, National cancer center, Republic of Korea
  • Study Director: Soon-Ae Lee, MD.PhD., Department of Anesthesiology and pain medicine, Research institute and hospital, National cancer center, Republic of Korea

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.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PICC1342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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