- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455348
Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care (KARTDISCHO)
February 27, 2018 updated by: Poitiers University Hospital
Dysfunctions radial arterial catheter are frequent.
This was a prospective, randomized observational study monocentric in ICU in France.
Patients are randomized in 2 groups : One to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint.
(Group B).
The primary outcome was the incidence of catheter dysfunction (defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve).
Investigators compared also the incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter and the cause of withdrawal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all patients admitted in ICU, older than 18 years and who required an arterial catheter are include
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: cathete to less than 4 four centimeters to the wrist joint
|
|
Active Comparator: catheter to more than four centimeters to the wrist joint
|
catheter insertion one to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint.
(Group B)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of dysfunction motivating catheter removal as a function of the distance from the carpal radio joint.
Time Frame: through study completion- 2 months
|
The dysfunction is defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve
|
through study completion- 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 4, 2017
First Submitted That Met QC Criteria
February 27, 2018
First Posted (Actual)
March 6, 2018
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- KARTDISCHO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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