Comparison of Two ECG Guided PICC Insertion Techniques

Chemotherapy Clinical Trial

Official title:

Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466332
• Other study ID #: 2020-00583
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2022
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.

Description:

One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 20, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Adult > 18 years
• Referred to the interventional radiology department for PICC insertion

Exclusion Criteria:

• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
• Enrolled in conflicting research study
• Weight> 150 kg, technical limit for the fluoroscopy table
• Impossibility of obtaining informed consent
• Refusal to be informed in the event of a chance discovery

Related Conditions & MeSH terms

• Central Venous Access
• Chemotherapy
• Long Term Antibiotics
• Total Parenteral Nutrition

Intervention

Device:
• LifeCath-CT PICC easy™ (Vygon)
ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity. The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve. The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.
• PowerPICC-SOLO® (C.R. Bard)
ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside. The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance from catheter tip to cavo-atrial junction (CAJ)	At the end of intervention tip position is measured on chest fluoroscopic X-ray.; Absolute distance in centimeters from tip to CAJ is measured on the image	At the end of intervention
Secondary	Length of the outgoing catheter	Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters	At the end of intervention
Secondary	Haemostasis time	Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)	At the end of intervention