An Intracavitary Electrocardiographic System for Real-time Positioning Peripherally Inserted Central Catheter Tip

Peripherally Inserted Central Catheter Clinical Trial

— PROJECT_EGG  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409589
• Other study ID #: 2015-001
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with malignant tumors who will require periodical infusion of chemotherapy drugs using three-valve PICC;

2. Aged >18 to < 80 years old;

3. Baseline ECG records prior to PICC catheter showed normal P wave;

4. Agreed to participate in this study, and signed PICC informed consent.

Exclusion Criteria:

5. 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.

6. Patients unable to lie in the prostrate or semi-supine position.

Related Conditions & MeSH terms

• Intracavitary Electrocardiogram Guiding
• Peripherally Inserted Central Catheter

Intervention

Device:
• ECG
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.

Procedure:
• Surface prediction length method
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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Yuan Ling

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single-time target rate		Less than 24 hours