- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405038
Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization (ILCDV)
February 1, 2019 updated by: Centre Hospitalier Régional Metz-Thionville
Prone Position Impact in Patients With Acute Respiratory Distress Syndrome on the Incidence of Central Venous Catheter Colonizations in Reanimation
Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit.
This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.
Study Overview
Status
Completed
Conditions
Detailed Description
Catheter-associated infection prevention is achieved by identification of the population at risk.
Patients receiving prone position Under acute respiratory distress syndrome appear to be particularly vulnerable.
This retrospective study is designed to compare the risk of catheter colonization that could be induced or worsened by prone position.
Knowing that, prone position is increased into the care acute respiratory distress syndrome since few years.
Unfortunately, no study has examined the prone position impact on catheter-association infection in these population.
Study Type
Observational
Enrollment (Actual)
202
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Metz, France, 57085
- CHR Metz Thionville
-
-
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
Sampling Method
Non-Probability Sample
Study Population
ARDS patients with a central venous catheter placed or not into prone position
Description
Inclusion Criteria:
- Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
- Patient with an acute respiratory distress syndrome, moderate or severe
- With a central venous catheter
- With or without prone position during the stay
Exclusion Criteria:
- Minor patient
- Absence of information on central venous catheter bacteriology
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the prone position
Time Frame: Day 1
|
Incidence rate of the bacterial colonization at least one catheter during the stay in resuscitation unit
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection associated factors
Time Frame: Day 1
|
multivariate analysis of risks factor for the catheter colonization ((age, sex, comorbidity, weight, length of stay)
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 2, 2017
Primary Completion (Actual)
June 4, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
January 12, 2018
First Submitted That Met QC Criteria
January 12, 2018
First Posted (Actual)
January 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02-CHRMT
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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