Catheter ComplicationsFIXATIONNCT05799989
Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients
An observational study of Catheter Complications, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of… Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Surgical fixation and Atraumatic fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2023to 30 Apr 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 Up to 19 years
- All sexes
- Child, Adult
Study population: pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
Who may be able to join
- pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
- estimated length of catheter left in place longer than 72 hours
Who cannot join
- estimated length of catheter left in place shorter than 72 hours
- impossible patient´s evaluation after catheter insertion
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno
Brno, South Moravian, 62500
Petr Štourač, prof.MD.Ph.D., MBA, 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD., 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients: Prospective Observational Trial
Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. Beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. In pediatric patients, due to limited cooperation, higher risk of dislocation exists.
Read the detailed description
Pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.Type of catheter fixation (surgical versus atraumatic) will be evaluated. Demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.
- Conditions
- Catheter Complications
- Being tested
- Surgical fixation, Atraumatic fixation
- Keywords
- intravenous, intraarterial, catheter, fixation, withdrawal, dislocation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical fixationProcedure or surgery
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation
Atraumatic fixationProcedure or surgery
Pediatric patients with intravenous and/or intraarterial catheter in situ secured with atraumatic fixation
| Study group | Role | What they receive |
|---|---|---|
| Surgical fixation | Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation Receives: Procedure: Surgical fixation | |
| Atraumatic fixation | Pediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation Receives: Procedure: Atraumatic fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter extraction/dislocation
The incidence of catheter extraction/dislocation will be evaluated between the group of surgical and atraumatic catheter fixation
Measured: In 30 days after catheter insertion
Secondary outcomes (3)
Incidence of local infectious complications
The incidence of local infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation
Measured: In 30 days after catheter insertion
Incidence of systemic infectious complications
The incidence of systemic infectious complications will be evaluated between the group of surgical and atraumatic catheter fixation
Measured: In 30 days after catheter insertion
Incidence of thrombotic complications
The incidence of thrombotic complications will be evaluated between the group of surgical and atraumatic catheter fixation
Measured: In 30 days after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jun 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799989
- Sponsor's protocol ID
- KDAR FIXATION 2023
- Acronym
- FIXATION
- Status last verified
- Jun 2023
- First submitted
- 23 Mar 2023
- Last updated
- 12 Jun 2023
- 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients: Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05799989
- Acronym / sponsor ID
- FIXATION / KDAR FIXATION 2023
- Conditions
- Catheter Complications
- Keywords
- intravenous, intraarterial, catheter, fixation, withdrawal, dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 5 Apr 2023 (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.
Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. Beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. In pediatric patients, due to limited cooperation, higher risk of dislocation exists.
Detailed description
Pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.Type of catheter fixation (surgical versus atraumatic) will be evaluated. Demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical fixation | – | Procedure: Surgical fixationPediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation |
| Atraumatic fixation | – | Procedure: Atraumatic fixationPediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
Key inclusion criteria (2 listed)
- pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
- estimated length of catheter left in place longer than 72 hours
Key exclusion criteria (2 listed)
- estimated length of catheter left in place shorter than 72 hours
- impossible patient´s evaluation after catheter insertion
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 |
|---|---|---|
| Surgical fixationPediatric patients with intravenous and/or intraarterial catheter in situ secured with surgical fixation | Procedure or surgery | Surgical fixation |
| Atraumatic fixationPediatric patients with intravenous and/or intraarterial catheter in situ secured with atraumatic fixation | Procedure or surgery | Atraumatic fixation |
Primary outcome
Incidence of catheter extraction/dislocation
Time frame: In 30 days after catheter insertion
The incidence of catheter extraction/dislocation will be evaluated between the group of surgical and atraumatic catheter fixation
3 secondary outcomes
Incidence of local infectious complications
Time frame: In 30 days after catheter insertion
Incidence of systemic infectious complications
Time frame: In 30 days after catheter insertion
Incidence of thrombotic complications
Time frame: In 30 days after catheter insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- 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.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
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 Complications, run by Brno University Hospital at 1 site in Czechia.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef UO Klučka, assoc.prof.MD., Ph.D. (+420532234696, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter extraction/dislocation (time frame: In 30 days after catheter insertion). 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 12 Jun 2023.