HemodynamicsCVPNCT01116973
Reliability of Central Venous Pressure Measurements
A study testing PICC in people with Hemodynamics and Central Venous Pressure, run by University of Oklahoma at 2 sites in United States.
Trial summary
The purpose of this study is to compare CVP measurements from CICCs and PICCs. The investigators will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodynamics, Central Venous Pressure
- What is being tested?
- PICC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2009to 27 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's ability to lay in a supine position with their hands at their sides during CVP measurements
- A consent form signed by the patient or patient's representative
- Subjects that are age 18-90
- Subjects that have an indwelling CICC and are transitioning to a PICC for long-term IV access
- CICC placed in the internal jugular vein or subclavian vein position
Who cannot join
- Inability to obtain consent
- Subjects under 18 years of age
- Non-English speaking subjects
- Subjects that are unable to lay flat due to pulmonary complications, increased intracranial pressure (ICP), or unstable spinal cord injuries
- Subjects with known cardiac abnormalities (atrial septal defects or ventricular septal defects, severe tricuspid valve disease, severe pulmonary hypertension, Ejection fraction < 15%)
- Prisoners
Show all 10Show fewer
- Subjects with known upper extremity deep vein thromboses (subclavian or distal)
- Subjects with non-functional CICC or PICC distal ports
- Subjects with femoral CICCs
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology
Oklahoma City, Oklahoma, 73104
Univeristy of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Reliability of Central Venous Pressure Measurements From Peripherally Inserted Central Catheters vs. Centrally Inserted Central Catheters
The purpose of this study is to compare CVP measurements from CICCs and PICCs. The investigators will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. The investigators hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
Read the detailed description
Centrally inserted central catheters (CICC) are commonly used in the intensive care unit (ICU) for delivery of fluids, medications, and nutrition. They are also used to measure central venous pressure (CVP) which provides critical information about blood volume status and cardiac function of a patient. Currently, CICCs are the gold standard for measuring CVP, but they have a number of associated risks including pneumothorax, major hemorrhage, neck hematoma, and carotid puncture. An alternative to a CICC is a peripherally inserted central catheter (PICC). A PICC can be placed with lower risks than a CICC, has a lower rate of bloodstream infections, and provides longer-term IV access at a lower cost. PICCs can be used to deliver fluids, medications, and nutrition. However, there is minimal evidence that a PICC can measure CVP as effectively as a CICC. Therefore, a CICC is preferred when a patient requires CVP monitoring in our ICU. Our aim is to compare CVP measurements from CICCs and PICCs. We will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
The goal of this study is to determine if the central venous pressure (CVP) measurements obtained from a peripherally inserted central catheter (PICC) consistently correlate with the CVP measurements obtained from a centrally inserted central catheter (CICC). If the difference between the CVP measurements from the CICC and PICC are found to be clinically insignificant, then it may be practical to place PICCs in favor of CICCs thereby avoiding some of the potential complications associated with CICC placement. We also aim to evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
- Conditions
- Hemodynamics, Central Venous Pressure
- Being tested
- PICC
- Keywords
- CVP monitoring compared with peripheral monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICCOther
Also called 18-gauge double lumen PICC
Peripheral inserted catheter placement to take the reading
| Study group | Role | What they receive |
|---|---|---|
| CICC comparison with PICC | Other | All patients will be having CVP reading taken from the CICC Receives: Other: PICC |
| PICC group | Other | The transition to the PICC, a 5.0-French, 18-gauge double lumen PICC (BARD, Power PICC Solo Catheter with Tip Location Stylet; Salt Lake City, UT) will be inserted Receives: Other: PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central venous pressure comparison with peripheral venous pressure
We will compare the realiablity of reading collected via central venous pressure reading and compare it with peripheral venous pressure reading.
Measured: 1 year
Secondary outcomes (1)
CICC reading comparison with PICC
This might also reduce the complications associated with CICC procedures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start2 Sep 2009
- Primary completion27 Aug 2016
- Study completion27 Aug 2016
Why it stopped: Change in guidelines by the manufacturer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Roberts, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116973
- Sponsor's protocol ID
- 1911
- Acronym
- CVP
- Status last verified
- May 2017
- First submitted
- 3 May 2010
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Central Venous Pressure Measurements From Peripherally Inserted Central Catheters vs. Centrally Inserted Central Catheters
- ClinicalTrials.gov ID
- NCT01116973
- Acronym / sponsor ID
- CVP / 1911
- Conditions
- Hemodynamics, Central Venous Pressure
- Keywords
- CVP monitoring compared with peripheral monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in guidelines by the manufacturer.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 2 Sep 2009 (actual)
- Primary completion
- 27 Aug 2016 (actual)
- Study completion
- 27 Aug 2016 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare CVP measurements from CICCs and PICCs. The investigators will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. The investigators hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
Detailed description
Centrally inserted central catheters (CICC) are commonly used in the intensive care unit (ICU) for delivery of fluids, medications, and nutrition. They are also used to measure central venous pressure (CVP) which provides critical information about blood volume status and cardiac function of a patient. Currently, CICCs are the gold standard for measuring CVP, but they have a number of associated risks including pneumothorax, major hemorrhage, neck hematoma, and carotid puncture. An alternative to a CICC is a peripherally inserted central catheter (PICC). A PICC can be placed with lower risks than a CICC, has a lower rate of bloodstream infections, and provides longer-term IV access at a lower cost. PICCs can be used to deliver fluids, medications, and nutrition. However, there is minimal evidence that a PICC can measure CVP as effectively as a CICC. Therefore, a CICC is preferred when a patient requires CVP monitoring in our ICU. Our aim is to compare CVP measurements from CICCs and PICCs. We will also evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
The goal of this study is to determine if the central venous pressure (CVP) measurements obtained from a peripherally inserted central catheter (PICC) consistently correlate with the CVP measurements obtained from a centrally inserted central catheter (CICC). If the difference between the CVP measurements from the CICC and PICC are found to be clinically insignificant, then it may be practical to place PICCs in favor of CICCs thereby avoiding some of the potential complications associated with CICC placement. We also aim to evaluate whether or not the duration of CICC placement affects the differences in CVP measurements between the CICCs and PICCs. We hypothesize that the differences between the CVP measurements of the CICCs and PICCs will be clinically insignificant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CICC comparison with PICC | Other | Other: PICCAll patients will be having CVP reading taken from the CICC |
| PICC group | Other | Other: PICCThe transition to the PICC, a 5.0-French, 18-gauge double lumen PICC (BARD, Power PICC Solo Catheter with Tip Location Stylet; Salt Lake City, UT) will be inserted |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject's ability to lay in a supine position with their hands at their sides during CVP measurements
- A consent form signed by the patient or patient's representative
- Subjects that are age 18-90
- Subjects that have an indwelling CICC and are transitioning to a PICC for long-term IV access
- CICC placed in the internal jugular vein or subclavian vein position
Key exclusion criteria (10 listed)
- Inability to obtain consent
- Subjects under 18 years of age
- Non-English speaking subjects
- Subjects that are unable to lay flat due to pulmonary complications, increased intracranial pressure (ICP), or unstable spinal cord injuries
- Subjects with known cardiac abnormalities (atrial septal defects or ventricular septal defects, severe tricuspid valve disease, severe pulmonary hypertension, Ejection fraction < 15%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICCAlso: 18-gauge double lumen PICCPeripheral inserted catheter placement to take the reading | Other | CICC comparison with PICC, PICC group |
Primary outcome
Central venous pressure comparison with peripheral venous pressure
Time frame: 1 year
We will compare the realiablity of reading collected via central venous pressure reading and compare it with peripheral venous pressure reading.
1 secondary outcome
CICC reading comparison with PICC
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Change in guidelines by the manufacturer.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Roberts, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICC in people with Hemodynamics and Central Venous Pressure, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in guidelines by the manufacturer.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central venous pressure comparison with peripheral venous pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.