An Intracavitary Electrocardiographic System for Real-time Positioning Peripherally Inserted Central Catheter Tip
PROJECT_EGG
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)
1 other identifier
interventional
1,007
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 14, 2022
April 1, 2022
3 months
April 1, 2015
April 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Single-time target rate
Less than 24 hours
Study Arms (2)
ECG-guided PICC Tip Placement
EXPERIMENTALNew intracavitary ECG guiding method
Conventional
ACTIVE COMPARATORSurface prediction length method
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuan Linglead
Study Sites (8)
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
Nanjing Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
The 2nd Affliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
People's Hospital Affiliated to Jiangsu University
Zhenjiang, Jiangsu, China
Related Publications (1)
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.
PMID: 28278167DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ling Yuan, Master
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Chief Nurse
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 7, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
April 14, 2022
Record last verified: 2022-04