Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2020-09-01
2021-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Saline ECG with Pilot Tip Location System
PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water
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.
Guidewire ECG with Sherlock Tip Confirmation System
PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Adult \> 18 years
* Referred to the interventional radiology department for PICC insertion
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
University of Lausanne
OTHER
Responsible Party
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Salah D. Qanadli, MD, PhD
Professor MD PhD
Principal Investigators
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Salah Dine Qanadli, Prof. MD PhD
Role: STUDY_DIRECTOR
UNIL-CHUV
Locations
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CHUV
Lausanne, Canton of Vaud, Switzerland
Countries
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Other Identifiers
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2020-00583
Identifier Type: -
Identifier Source: org_study_id
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