Peripherally Inserted Central CatheterPROJECT_EGGNCT02409589
An Intracavitary Electrocardiographic System for Real-time Positioning Peripherally Inserted Central Catheter Tip
A study testing ECG and Surface prediction length method in people with Peripherally Inserted Central Catheter and Intracavitary Electrocardiogram Guiding, run by Yuan Ling at 8 sites in China.
Trial summary
The purpose of this study is to compare a new intracavitary ECG guiding method for real-time positioning the tip of three-way valve type peripherally inserted central catheters versus conventional surface prediction length method in terms of single-time target rate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripherally Inserted Central Catheter, Intracavitary Electrocardiogram Guiding
- What is being tested?
- ECG and Surface prediction length method
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,007 participants
- Where
- 8 sitesChina
- Study dates
- Mar 2015to Oct 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with malignant tumors who will require periodical infusion of chemotherapy drugs using three-valve PICC;
- Aged >18 to < 80 years old;
- Baseline ECG records prior to PICC catheter showed normal P wave;
- Agreed to participate in this study, and signed PICC informed consent.
Who cannot join
- Patients with heart diseases, such as valvular heart disease, atrial fibrillation, supraventricular tachycardia, pulmonary heart disease or having a pacemaker and post cardiac surgery which may affect P waves.
- Patients unable to lie in the prostrate or semi-supine position.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu
Nanjing Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu
The 2nd Affliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
People's Hospital Affiliated to Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Randomized Open-labeled Multicenter Study to Assess a New Intracavitary Electrocardiographic Guiding Method for Real-time Positioning the Tip of Three-way Valve Type Peripherally Inserted Central Catheters (PROJECT_EGG)
The purpose of this study is to compare a new intracavitary ECG guiding method for real-time positioning the tip of three-way valve type peripherally inserted central catheters versus conventional surface prediction length method in terms of single-time target rate.
Read the detailed description
The use of peripherally inserted central catheters (PICCs) has increased significantly for cancer patients receiving chemotherapy. For these patients, PICCs afford many advantages with regards to complications and treatment convenience.
Current practice utilizes the estimated length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) for guiding tip placement. Next the catheter tip placement was confirmed by radiographic imaging prior to use of the line for administration of chemotherapy medications. In this case, the catheter is often mal-positioned and requires adjustment and repeat radiographic imaging in order to ensure proper placement, ideally at the SVC-RA junction. These potentially additional procedures are time-consuming and also expose patients, nurses and physicians to radiations.
Intracavitary electrocardiogram with an electrode placed inside the catheter during insertion has shown identifiable changes in P-wave, which are sufficient to guide PICC tip placement. Moreover, less procedural time and radiation are expected.
This study aims to demonstrate if this intracavitary electrocardiogram guided method is superior to conventional surface prediction length method in terms of single-time target rate of correct tip placement. In addition, we would like to investigate symptomatic thrombosis incidence and its risk factors after three-valve PICC implanted among patients with malignant tumors; to clarify procedure time used and cost of the new intracavitary ECG guiding method and to explore the maximal P-wave amplitude of intracavity ECG real-time positioning technology and its predictive factors.
- Being tested
- ECG, Surface prediction length method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
The ECG-guided PICC tip detection method will be used to identify catheter tip location during the procedural placement of the catheter. This method involves an ECG monitor which will be connected to the guidewire used for catheter placement. The changes in the ECG p-wave will guide correct PICC placement. An X-ray radiograph will be conducted to confirm the tip location after PICC placement.
Surface prediction length methodProcedure or surgery
The method will estimate the length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) . Tip location is placed according to the estimated length but later on will be determinated by chest X-ray performed after the placement procedure. If the tip location is not at an ideal place, additional procedures and X-ray radiograph would be required in order to ensure proper tip location.
| Study group | Role | What they receive |
|---|---|---|
| ECG-guided PICC Tip Placement | Experimental | New intracavitary ECG guiding method Receives: Device: ECG |
| Conventional | Active comparator | Surface prediction length method Receives: Procedure: Surface prediction length method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-time target rate
Measured: Less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripherally Inserted Central CatheterStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuan Ling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuan Ling, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Ling Yuan, Master, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409589
- Sponsor's protocol ID
- 2015-001
- Acronym
- PROJECT_EGG
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2015
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, Chen P, Qiu Z, Qi J, Chen C, Wei J, Qin M, Kong W, Chen X, Xu W. Superior success rate of intracavitary electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multicenter study. PLoS One. 2017 Mar 9;12(3):e0171630. doi: 10.1371/journal.pone.0171630. eCollection 2017.
PubMed 28278167
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-labeled Multicenter Study to Assess a New Intracavitary Electrocardiographic Guiding Method for Real-time Positioning the Tip of Three-way Valve Type Peripherally Inserted Central Catheters (PROJECT_EGG)
- ClinicalTrials.gov ID
- NCT02409589
- Acronym / sponsor ID
- PROJECT_EGG / 2015-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Yuan LingUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Apr 2015 (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 a new intracavitary ECG guiding method for real-time positioning the tip of three-way valve type peripherally inserted central catheters versus conventional surface prediction length method in terms of single-time target rate.
Detailed description
The use of peripherally inserted central catheters (PICCs) has increased significantly for cancer patients receiving chemotherapy. For these patients, PICCs afford many advantages with regards to complications and treatment convenience.
Current practice utilizes the estimated length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) for guiding tip placement. Next the catheter tip placement was confirmed by radiographic imaging prior to use of the line for administration of chemotherapy medications. In this case, the catheter is often mal-positioned and requires adjustment and repeat radiographic imaging in order to ensure proper placement, ideally at the SVC-RA junction. These potentially additional procedures are time-consuming and also expose patients, nurses and physicians to radiations.
Intracavitary electrocardiogram with an electrode placed inside the catheter during insertion has shown identifiable changes in P-wave, which are sufficient to guide PICC tip placement. Moreover, less procedural time and radiation are expected.
This study aims to demonstrate if this intracavitary electrocardiogram guided method is superior to conventional surface prediction length method in terms of single-time target rate of correct tip placement. In addition, we would like to investigate symptomatic thrombosis incidence and its risk factors after three-valve PICC implanted among patients with malignant tumors; to clarify procedure time used and cost of the new intracavitary ECG guiding method and to explore the maximal P-wave amplitude of intracavity ECG real-time positioning technology and its predictive factors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG-guided PICC Tip Placement | Experimental | Device: ECGNew intracavitary ECG guiding method |
| Conventional | Active comparator | Procedure: Surface prediction length methodSurface prediction length method |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with malignant tumors who will require periodical infusion of chemotherapy drugs using three-valve PICC;
- Aged >18 to < 80 years old;
- Baseline ECG records prior to PICC catheter showed normal P wave;
- Agreed to participate in this study, and signed PICC informed consent.
Key exclusion criteria (2 listed)
- Patients with heart diseases, such as valvular heart disease, atrial fibrillation, supraventricular tachycardia, pulmonary heart disease or having a pacemaker and post cardiac surgery which may affect P waves.
- Patients unable to lie in the prostrate or semi-supine position.
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 |
|---|---|---|
| ECGThe ECG-guided PICC tip detection method will be used to identify catheter tip location during the procedural placement of the catheter. This method involves an ECG monitor which will be connected to the guidewire used for catheter placement. The changes in the ECG p-wave will guide correct PICC placement. An X-ray radiograph will be conducted to confirm the tip location after PICC placement. | Device | ECG-guided PICC Tip Placement |
| Surface prediction length methodThe method will estimate the length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) . Tip location is placed according to the estimated length but later on will be determinated by chest X-ray performed after the placement procedure. If the tip location is not at an ideal place, additional procedures and X-ray radiograph would be required in order to ensure proper tip location. | Procedure or surgery | Conventional |
Primary outcome
Single-time target rate
Time frame: Less than 24 hours
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 14 Apr 2022.
- Derived from this study: PubMed 28278167Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, Chen P, Qiu Z, Qi J, Chen C, Wei J, Qin M, Kong W, Chen X, Xu W. Superior success rate of intracavitary electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multicenter study. PLoS One. 2017 Mar 9;12(3):e0171630. doi: 10.1371/journal.pone.0171630. eCollection 2017.
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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.
Ling Yuan, Master principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG and Surface prediction length method in people with Peripherally Inserted Central Catheter and Intracavitary Electrocardiogram Guiding, run by Yuan Ling at 8 sites in China.
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 4 inclusion and 2 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
Single-time target rate (time frame: Less than 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409589, which also lists 1 linked publication.
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 14 Apr 2022.