Catheter Related ComplicationsAdvancedNCT01795391
Comparison of Two New Generations Dressings in Intensive Care Unit
An observational study of Catheter Related Complications, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Related Complications
- How many people
- 685 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Nov 2013
- Phase
- Observational
- 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
Study population: Patients hospitalised in the Medical ICU and requiring an intravascular device during hospitalisation (peripheral or central)
Who may be able to join
- Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.
- Patients benefiting from the social security protection.
Who cannot join
- Patients under 18 years of age,
- Patients having known allergy or sensitivity to adhesive dressing materials
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Grenoble, Medical Intensive Care Unit
Grenoble, Isère, 38043
About this study
Official title: Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units
Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.
- Conditions
- Catheter Related Complications
- Keywords
- Prevention, Dressings, Catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tegaderm HP | Patients whose intravasculare devices dressings are made exclusevely with Tegaderm HP dressings. | |
| Advanced | Patients whose intravasculare devices dressings are made exclusevely with Advanced dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of catheters presenting any kind of complications.
Measured: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Secondary outcomes (1)
Number of infections related to poor adherent dressings.
Measured: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795391
- Sponsor's protocol ID
- ADVANCED
- Acronym
- Advanced
- Status last verified
- Jan 2014
- First submitted
- 18 Feb 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units
- ClinicalTrials.gov ID
- NCT01795391
- Acronym / sponsor ID
- Advanced / ADVANCED
- Conditions
- Catheter Related Complications
- Keywords
- Prevention, Dressings, Catheters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Feb 2013 (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.
Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegaderm HP | – | –Patients whose intravasculare devices dressings are made exclusevely with Tegaderm HP dressings. |
| Advanced | – | –Patients whose intravasculare devices dressings are made exclusevely with Advanced dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in the Medical ICU and requiring an intravascular device during hospitalisation (peripheral or central)
Key inclusion criteria (2 listed)
- Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.
- Patients benefiting from the social security protection.
Key exclusion criteria (2 listed)
- Patients under 18 years of age,
- Patients having known allergy or sensitivity to adhesive dressing materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of catheters presenting any kind of complications.
Time frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
1 secondary outcome
Number of infections related to poor adherent dressings.
Time frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
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 22 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Related Complications, run by University Hospital, Grenoble at 1 site in France.
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 22 Jan 2014. 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 France. 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 catheters presenting any kind of complications. (time frame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.). 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 22 Jan 2014.