Back to resultsECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
Primary Purpose
Infection, Cancer, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ECG-guided insertion of PICC
ULTRASOUND-guided insertion of PICC
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring ECG, Ultrasound, Peripherally Inserted Central Catheters, PICC
Eligibility Criteria
Inclusion Criteria:
- All adults with indication for PICC
Exclusion Criteria:
- Age <18y
- Pregnant women
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ECG-guided insertion of PICC
ULTRASOUND-guided insertion of PICC
Arm Description
Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion.
Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided.
Outcomes
Primary Outcome Measures
Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion
The aim of the study is a comparison between two techniques to control correct positioning of the PICC
Secondary Outcome Measures
Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
frequency of necessity of replacement after chest-x-ray control
PICC tip should be located in the superior caval vein, close to the entrance of the right atrium. Other locations lead to repositioning.
Full Information
NCT ID
NCT02467049
First Posted
May 26, 2015
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02467049
Brief Title
ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
Official Title
ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.
Detailed Description
This is a randomised prospective single blinded study. All adult patients with an indication for PICC placement can be included. Patients will be randomised into two groups, one with ECG-guided placement followed by ultrasound control and the other with only ultrasound guided placement. After placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. For the ECG-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. For the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Cancer, Malnutrition
Keywords
ECG, Ultrasound, Peripherally Inserted Central Catheters, PICC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECG-guided insertion of PICC
Arm Type
Active Comparator
Arm Description
Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion.
Arm Title
ULTRASOUND-guided insertion of PICC
Arm Type
Experimental
Arm Description
Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided.
Intervention Type
Device
Intervention Name(s)
ECG-guided insertion of PICC
Intervention Description
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
Intervention Type
Device
Intervention Name(s)
ULTRASOUND-guided insertion of PICC
Intervention Description
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
Primary Outcome Measure Information:
Title
Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion
Description
The aim of the study is a comparison between two techniques to control correct positioning of the PICC
Time Frame
Whitin 5 minutes after catheter-placement
Secondary Outcome Measure Information:
Title
Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
Time Frame
within 5 minutes
Title
frequency of necessity of replacement after chest-x-ray control
Description
PICC tip should be located in the superior caval vein, close to the entrance of the right atrium. Other locations lead to repositioning.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adults with indication for PICC
Exclusion Criteria:
Age <18y
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucie Choustoulakis, MD
Organizational Affiliation
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, MD, PhD
Organizational Affiliation
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthias Raes, MD
Organizational Affiliation
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
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