Long-term Venous AccessNCT04444479
Insertion of PICC With Intracavitary ECG Navigation
A study testing ECG verification and X-ray verification in people with Long-term Venous Access, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Venous Access
- What is being tested?
- ECG verification and X-ray verification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Jun 2020to 30 Apr 2023
- 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
- indication for establishing long-term venous access
- 18 years of age and over
Who cannot join
- oncological patients
- non-signing the informed consent form
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray
The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.
Read the detailed description
The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.
Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.
- Conditions
- Long-term Venous Access
- Being tested
- ECG verification, X-ray verification
- Keywords
- peripherally inserted central catheter, ECG navigation, chest x-ray, PICC tip navigation, catheter tip location, intracavitary ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG verificationOther
The correct positioning of the PICC catheter tip will be verified using ECG.
X-ray verificationOther
The correct positioning of the PICC catheter tip will be verified using X-ray imaging.
| Study group | Role | What they receive |
|---|---|---|
| PICC catheter placement | Experimental | Study subjects in whom placement of the PICC catheter is indicated Receives: Other: ECG verification; Other: X-ray verification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval between ECG and X-ray
The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.
Measured: 2 hours
Secondary outcomes (1)
Success-rate of correct PICC tip location
The success-rate of correct PICC tip location will be determined using ECG navigation against the use of chest X-ray, and expressed as distance in centimetres from the target point.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Jun 2020
- Primary completion31 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Long-term Venous AccessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iveta Constantine, Bc.,MSc., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444479
- Sponsor's protocol ID
- PICC-07-ECG_Navigation
- Other IDs
- 07/ RVO- FNOs/ 2020, MH CZ - DRO - FNOs/2020
- Status last verified
- Sep 2023
- First submitted
- 19 Jun 2020
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.
PubMed 21667458Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.
PubMed 27231736Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.
PubMed 25040430
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray
- ClinicalTrials.gov ID
- NCT04444479
- Acronym / sponsor ID
- PICC-07-ECG_Navigation
- Conditions
- Long-term Venous Access
- Keywords
- peripherally inserted central catheter, ECG navigation, chest x-ray, PICC tip navigation, catheter tip location, intracavitary ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 23 Jun 2020 (actual)
- 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.
The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.
Detailed description
The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.
Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
| Arm | Type | Receives |
|---|---|---|
| PICC catheter placement | Experimental | Other: ECG verification, Other: X-ray verificationStudy subjects in whom placement of the PICC catheter is indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication for establishing long-term venous access
- 18 years of age and over
Key exclusion criteria (2 listed)
- oncological patients
- non-signing the informed consent form
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 verificationThe correct positioning of the PICC catheter tip will be verified using ECG. | Other | PICC catheter placement |
| X-ray verificationThe correct positioning of the PICC catheter tip will be verified using X-ray imaging. | Other | PICC catheter placement |
Primary outcome
Time interval between ECG and X-ray
Time frame: 2 hours
The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.
1 secondary outcome
Success-rate of correct PICC tip location
Time frame: 2 hours
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 11 Sep 2023.
- Background: PubMed 21667458Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.
- Background: PubMed 27231736Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.
- Background: PubMed 25040430Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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.
Iveta Constantine, Bc.,MSc. principal investigator
University Hospital Ostrava
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 verification and X-ray verification in people with Long-term Venous Access, run by University Hospital Ostrava at 1 site in Czechia.
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 2 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 11 Sep 2023. 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 Czechia. 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?
Time interval between ECG and X-ray (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444479, which also lists 3 linked publications.
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 11 Sep 2023.