- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05495646
Infection Related to Short-term Central Venous Catheters
Infection Related to Short-term Central Venous Catheters: an Observational Study in Surgical Patients
This study aims to evaluate the incidence of infection of short-term central venous catheters by comparing different cannulation techniques (by anatomical references and under ultrasound control) and according to the experience of the operator in patients undergoing elective surgery.
A prospective observational study will be carried out in which all scheduled surgery patients who have a central venous line inserted for 12 months will be included. Those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded from this study. A chest X-ray will be performed on all patients in order to diagnose possible complications associated with the technique and, only in case of suspected infection, culture of the catheter tip and blood cultures of blood obtained from the catheter and peripheral blood will be requested.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A prospective observational study will be carried out. The maximum time between the intervention and the final evaluation will be 21 days, since the study evaluates the infection related to short-term catheters and its probable improvement after the removal of the device.
All patients undergoing elective surgery who have a central venous line inserted for 12 months will be included in the study. Those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded.
A follow-up of the central venous catheters that are inserted in those patients scheduled for surgery who have an indication for it will be carried out. The criteria for choosing the access route will be carried out according to the usual clinical practice of the responsible anesthesiologist.
The asepsis measures that will be carried out both in the insertion and in the maintenance of the catheter will be those used on a regular basis, which follow the recommendations of the guidelines for the prevention of infections related to intravascular catheters of the American Center for Control and Prevention. of Diseases.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Las Palmas
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Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
- Ángel Becerra
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs
Exclusion Criteria:
- Patients under 18 years of age
- Patients who need to wear the central venous catheter for more than 14 days
- Patients who do not sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of infection among short-term central venous catheters inserted in the scheduled perioperative setting.
Time Frame: From the immediate postoperative period to the 21st postoperative day
|
Review of the clinical follow-up of each patient to evaluate the appearance of catheter related infection through its clinical manifestations and microbiological data.
|
From the immediate postoperative period to the 21st postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients suffering from complications after the different techniques and operators.
Time Frame: From the immediate postoperative period to the first postoperative day
|
Review of the clinical follow-up of each patient to evaluate the technique of inserting the central venous catheter.
|
From the immediate postoperative period to the first postoperative day
|
|
Assess risk factors for catheter-related infection
Time Frame: From the immediate postoperative period to the 21st postoperative day
|
Review of the medical records and the clinical follow-up of each patient to evaluate the risk factors for suffering from catheter-related infection.
|
From the immediate postoperative period to the 21st postoperative day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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