Infection Related to Short-term Central Venous Catheters

Sponsor
Ángel Becerra (Other)
Overall Status
Recruiting
CT.gov ID
NCT05495646
Collaborator
(none)
150
1
4.7
31.7

Study Details

Study Description

Brief 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 one month 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Central catheter insertion

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 three 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Infection Related to Short-term Central Venous Catheters: an Observational Study in Surgical Patients
Actual Study Start Date :
Aug 8, 2022
Anticipated Primary Completion Date :
Nov 8, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Incidence of infection among short-term central venous catheters inserted in the scheduled perioperative setting. [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.

Secondary Outcome Measures

  1. Number of patients suffering from complications after the different techniques and operators. [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.

  2. Assess risk factors for catheter-related infection [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ángel Becerra Las Palmas De Gran Canaria Las Palmas Spain 35019

Sponsors and Collaborators

  • Ángel Becerra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier:
NCT05495646
Other Study ID Numbers:
  • 150030
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022