Catheter-Related InfectionsNCT05495646
Infection Related to Short-term Central Venous Catheters
An observational study of Catheter-Related Infections, run by Ángel Becerra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Central catheter insertion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 8 Aug 2022to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery during the three months in which the study is carried out who need a central venous catheter.
Who may be able to join
- Patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Catheter-Related Infections
- Being tested
- Central catheter insertion
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central catheter insertionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Review of the clinical follow-up of each patient to evaluate the technique of inserting the central venous catheter.
Measured: From the immediate postoperative period to the first postoperative day
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.
Measured: From the immediate postoperative period to the 21st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start8 Aug 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ángel Becerra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495646
- Sponsor's protocol ID
- 150030
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Related to Short-term Central Venous Catheters: an Observational Study in Surgical Patients
- ClinicalTrials.gov ID
- NCT05495646
- Acronym / sponsor ID
- 150030
- Conditions
- Catheter-Related Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ángel BecerraUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery during the three months in which the study is carried out who need a central venous catheter.
Key inclusion criteria (1 listed)
- Patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central catheter insertionThe 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. | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Number of patients suffering from complications after the different techniques and operators.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections, run by Ángel Becerra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.