|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03652727 |
|
Date of registration:
|
27/08/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
FX vs. ECG Guidance for PICC Insertion
|
|
Scientific title:
|
Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT |
|
Date of first enrolment:
|
September 4, 2018 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03652727 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Salah Dine Qanadli, Prof. MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UNIL-CHUV |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Informed Consent as documented by signature (Informed Consent Form)
- Adult > 18 years
- Referred to the interventional radiology department for PICC insertion
Exclusion Criteria:
- Pregnant women
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chemotherapy
|
|
Long Term Antibiotics
|
|
Total Parenteral Nutrition
|
|
Intervention(s)
|
|
Device: ECG-EM Guidance
|
|
Device: FX Guidance
|
|
Primary Outcome(s)
|
|
Tip to CAJ (Cavo-atrial junction)
[Time Frame: Up to 1 hour, after the procedure]
|
|
Secondary Outcome(s)
|
|
Inter-observer and intra-observer variance
[Time Frame: Through study completion, an average of 9 month]
|
|
Length of the outgoing catheter
[Time Frame: Up to 1 hour, after the procedure]
|
|
Secondary ID(s)
|
|
2018-00907
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|