NCT05495646

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

August 5, 2022

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    From the immediate postoperative period to the first postoperative day

  • Assess risk factors for catheter-related infection

    From the immediate postoperative period to the 21st postoperative day

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 10, 2022

Study Start

August 8, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations