Peripherally Inserted Central CathetersPUPNCT03954977
Point of Care Ultrasound for PICC Line Monitoring Study
A study testing PICC line ultrasound in people with Peripherally Inserted Central Catheters, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Peripherally Inserted Central Catheters
- What is being tested?
- PICC line ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2019to 30 Aug 2019
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- NICU patient at Seattle Childrens Hospital or University of Washington
- Patient has a PICC line in place
Who cannot join
- vertebral anomalies
- anomalies of venous anatomy
- tracheal anomalies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Childrens Hospital
Seattle, Washington, 98105
University Of Washington
Seattle, Washington, 98195
About this study
A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
Read the detailed description
Point of care (POC) ultrasound has become an invaluable tool for critically ill children. Several studies have been completed detailing its use for central line access and determining the location of the tip of umbilical venous lines. There are no current studies on monitoring PICC line tip placement using POC ultrasound. There have been studies showing ultrasound can be used to locate PICC line tip location, but none for monitoring. A previous study found that the sensitivity and specificity of US in identifying the location of PICC line tip were 86% and 75% respectively.
Review of the literature notes that Costa et al also found a high rate of PICC line complications. Costa et al and the investigators local experience also highlight the rare but potentially fatal complication of pericardial effusion from PICC lines that are too deep in the heart. One way the investigators could improve the safety of neonatal PICC lines is monitor them more closely. Current standard of care is to monitor PICC line tips on chest x-ray. Unfortunately, there is strong evidence that chest x-ray does not accurately identify the PICC line tip location. Another way would be to use POC ultrasound. A literature review on POC ultrasound to determine the location of a PICC line tip revealed that no such study has been done. Several studies have been completed demonstrating POC ultrasound both improved success rate and time to confirmation of placement of PICC lines.3 Pulickal et al published data on teaching pediatric residents to do point of care ultrasound to determine the location of the UVC tip. The investigators in that study found the residents were not only better at determining the correct location than chest x-ray, but the procedure was well tolerated. The investigators for this study feel further evaluation of POC ultrasound for PICC line tip monitoring to determine feasibility and accuracy is needed.
Eligible patients will be identified by the NICU care team. Participants will then be consented for the study by the study team. Trained Neonatology Fellows/Attendings will perform POC ultrasound to identify and document the PICC tip location and will be blinded to the PICC line tip location on x-ray. Ultrasounds will only be performed during patient's care times and be limited to 15 minutes.
- Conditions
- Peripherally Inserted Central Catheters
- Being tested
- PICC line ultrasound
- Keywords
- PICC line, Neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC line ultrasoundDiagnostic test
NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound vs Radiograph | Experimental | NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray. Receives: Diagnostic Test: PICC line ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICC line tip is located by the ultrasound operator
PICC line identified under ultrasound
Measured: 6 months
Secondary outcomes (1)
PICC line location on ultrasound agrees with radiograph
PICC line localization on ultrasound is the same as the localization of the PICC line on radiograph
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start10 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripherally Inserted Central CathetersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Patrick Motz, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954977
- Sponsor's protocol ID
- 0503
- Acronym
- PUP
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound for PICC Line Monitoring Study
- ClinicalTrials.gov ID
- NCT03954977
- Acronym / sponsor ID
- PUP / 0503
- Conditions
- Peripherally Inserted Central Catheters
- Keywords
- PICC line, Neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 May 2019 (actual)
- 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.
A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
Detailed description
Point of care (POC) ultrasound has become an invaluable tool for critically ill children. Several studies have been completed detailing its use for central line access and determining the location of the tip of umbilical venous lines. There are no current studies on monitoring PICC line tip placement using POC ultrasound. There have been studies showing ultrasound can be used to locate PICC line tip location, but none for monitoring. A previous study found that the sensitivity and specificity of US in identifying the location of PICC line tip were 86% and 75% respectively.
Review of the literature notes that Costa et al also found a high rate of PICC line complications. Costa et al and the investigators local experience also highlight the rare but potentially fatal complication of pericardial effusion from PICC lines that are too deep in the heart. One way the investigators could improve the safety of neonatal PICC lines is monitor them more closely. Current standard of care is to monitor PICC line tips on chest x-ray. Unfortunately, there is strong evidence that chest x-ray does not accurately identify the PICC line tip location. Another way would be to use POC ultrasound. A literature review on POC ultrasound to determine the location of a PICC line tip revealed that no such study has been done. Several studies have been completed demonstrating POC ultrasound both improved success rate and time to confirmation of placement of PICC lines.3 Pulickal et al published data on teaching pediatric residents to do point of care ultrasound to determine the location of the UVC tip. The investigators in that study found the residents were not only better at determining the correct location than chest x-ray, but the procedure was well tolerated. The investigators for this study feel further evaluation of POC ultrasound for PICC line tip monitoring to determine feasibility and accuracy is needed.
Eligible patients will be identified by the NICU care team. Participants will then be consented for the study by the study team. Trained Neonatology Fellows/Attendings will perform POC ultrasound to identify and document the PICC tip location and will be blinded to the PICC line tip location on x-ray. Ultrasounds will only be performed during patient's care times and be limited to 15 minutes.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound vs Radiograph | Experimental | Diagnostic Test: PICC line ultrasoundNICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- NICU patient at Seattle Childrens Hospital or University of Washington
- Patient has a PICC line in place
Key exclusion criteria (3 listed)
- vertebral anomalies
- anomalies of venous anatomy
- tracheal anomalies.
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 |
|---|---|---|
| PICC line ultrasoundNICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray. | Diagnostic test | Ultrasound vs Radiograph |
Primary outcome
PICC line tip is located by the ultrasound operator
Time frame: 6 months
PICC line identified under ultrasound
1 secondary outcome
PICC line location on ultrasound agrees with radiograph
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Peripherally Inserted Central Catheters
RecruitingPhase 3
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Effects of Different PICC Catheterization Methods: A Multicenter Randomized Controlled Trial
Cancer Patients
Not yet recruitingObservational study
Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity
PICC Line Placement, Vessels; Anomaly
RecruitingObservational study
Magnetic Tracking and ECG-Guided Tip Confirmation System for PICCs
Peripherally Inserted Central Catheters
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.
The record lists no contact. Use the official record to reach the sponsor.
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 line ultrasound in people with Peripherally Inserted Central Catheters, run by Seattle Children's Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Sep 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PICC line tip is located by the ultrasound operator (time frame: 6 months). 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 26 Sep 2019.