InfectionNCT02467049
ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
A study testing ECG-guided insertion of PICC and ULTRASOUND-guided insertion of PICC in people with Infection and Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Cancer, Malnutrition
- What is being tested?
- ECG-guided insertion of PICC and ULTRASOUND-guided insertion of PICC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults with indication for PICC
Who cannot join
- Age <18y
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infection, Cancer, Malnutrition
- Being tested
- ECG-guided insertion of PICC, ULTRASOUND-guided insertion of PICC
- Keywords
- ECG, Ultrasound, Peripherally Inserted Central Catheters, PICC
- Medical subject headings
- Infections, Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-guided insertion of PICCDevice
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
ULTRASOUND-guided insertion of PICCDevice
Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
| Study group | Role | What they receive |
|---|---|---|
| ECG-guided insertion of PICC | Active comparator | Placement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion. Receives: Device: ECG-guided insertion of PICC; Device: ULTRASOUND-guided insertion of PICC |
| ULTRASOUND-guided insertion of PICC | Experimental | Placement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided. Receives: Device: ECG-guided insertion of PICC; Device: ULTRASOUND-guided insertion of PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Whitin 5 minutes after catheter-placement
Secondary outcomes (2)
Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
Measured: within 5 minutes
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Lucie Choustoulakis, MD, Principal investigator, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.Jan Poelaert, MD, PhD, Study chair, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.Matthias Raes, MD, Principal investigator, Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467049
- Sponsor's protocol ID
- ECG-PICC
- Status last verified
- Apr 2019
- First submitted
- 26 May 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
- ClinicalTrials.gov ID
- NCT02467049
- Acronym / sponsor ID
- ECG-PICC
- Conditions
- Infection, Cancer, Malnutrition
- Keywords
- ECG, Ultrasound, Peripherally Inserted Central Catheters, PICC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG-guided insertion of PICC | Active comparator | Device: ECG-guided insertion of PICC, Device: ULTRASOUND-guided insertion of PICCPlacement of the PICC (Peripherally Inserted Central Catheter ) ECG-guided insertion. |
| ULTRASOUND-guided insertion of PICC | Experimental | Device: ECG-guided insertion of PICC, Device: ULTRASOUND-guided insertion of PICCPlacement of the PICC (Peripherally Inserted Central Catheter ) ULTRASOUND-guided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults with indication for PICC
Key exclusion criteria (2 listed)
- Age <18y
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG-guided insertion of PICCComparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance | Device | ECG-guided insertion of PICC, ULTRASOUND-guided insertion of PICC |
| ULTRASOUND-guided insertion of PICCComparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance | Device | ECG-guided insertion of PICC, ULTRASOUND-guided insertion of PICC |
Primary outcome
Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion
Time frame: Whitin 5 minutes after catheter-placement
The aim of the study is a comparison between two techniques to control correct positioning of the PICC
2 secondary outcomes
Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
Time frame: within 5 minutes
frequency of necessity of replacement after chest-x-ray control
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Choustoulakis, MD principal investigator
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
Jan Poelaert, MD, PhD study chair
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
Matthias Raes, MD principal investigator
Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG-guided insertion of PICC and ULTRASOUND-guided insertion of PICC in people with Infection and Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion (time frame: Whitin 5 minutes after catheter-placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.