Infection Related to Short-term Central Venous Catheters

July 23, 2024 updated by: Ángel Becerra

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

Completed

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

Observational

Enrollment (Actual)

200

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

    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
        • Ángel Becerra

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

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective surgery during the three months in which the study is carried out who need a central venous catheter.

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

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

  • 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

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)

August 8, 2022

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 150030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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