Dysfunctions Arterial CatheterKARTDISCHONCT03455348
Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care
A study testing catheter insertion in people with Dysfunctions Arterial Catheter, run by Poitiers University Hospital.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctions Arterial Catheter
- What is being tested?
- catheter insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2016to 1 Jun 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 patients admitted in ICU, older than 18 years and who required an arterial catheter are include
Who cannot join
None listed.
About this study
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.
- Conditions
- Dysfunctions Arterial Catheter
- Being tested
- catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter insertionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| cathete to less than 4 four centimeters to the wrist joint | No intervention | Not described |
| catheter to more than four centimeters to the wrist joint | Active comparator | Not described Receives: Other: catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of dysfunction motivating catheter removal as a function of the distance from the carpal radio joint.
The dysfunction is defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve
Measured: through study completion- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start22 Jan 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctions Arterial CatheterStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455348
- Sponsor's protocol ID
- KARTDISCHO
- Acronym
- KARTDISCHO
- Status last verified
- Dec 2017
- First submitted
- 4 Oct 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Radial Arterial Location on Arterial Catheter Lifetime in Surgical Intensive Care
- ClinicalTrials.gov ID
- NCT03455348
- Acronym / sponsor ID
- KARTDISCHO / KARTDISCHO
- Conditions
- Dysfunctions Arterial Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 6 Mar 2018 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cathete to less than 4 four centimeters to the wrist joint | No intervention | – |
| catheter to more than four centimeters to the wrist joint | Active comparator | Other: catheter insertion |
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 patients admitted in ICU, older than 18 years and who required an arterial catheter are include
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| catheter insertioncatheter 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) | Other | catheter to more than four centimeters to the wrist joint |
Primary outcome
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
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 6 Mar 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing catheter insertion in people with Dysfunctions Arterial Catheter, run by Poitiers University Hospital.
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 0 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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). 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 6 Mar 2018.