Infection Related to Short-term Central Venous Catheters

Catheter-Related Infections Clinical Trial

Official title:

Infection Related to Short-term Central Venous Catheters: an Observational Study in Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495646
• Other study ID #: 150030
• Status: Recruiting
• Start date: August 8, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: Dr. Negrin University Hospital
• Contact: Yurena Domínguez, MD
• Phone: +34928450370
• Email: yurena.dd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infections

Intervention

Procedure:
• Central catheter insertion
The data will be obtained through the review of the medical records and the clinical follow-up of each patient to evaluate the technique of inserting the device, the possible risk factors of catheter-related infection, its clinical manifestations and the data microbiological.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
Ángel Becerra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infection among short-term central venous catheters inserted in the scheduled perioperative setting.	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	Number of patients suffering from complications after the different techniques and operators.	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
Secondary	Assess risk factors for catheter-related infection	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