Infection following a procedure not elsewhere classified
Conditions
Interventions
This is a randomized, controlled, parallel and open clinical trial. Children/adolescents between 0 days of age and 15 years of age who will require insertion of peripherally inserted central catheters
Sponsors
Universidade Federal de Santa Catarina
Hospital Infantil Joana de Gusmão
Eligibility
Age
No minimum to 14 Years
Inclusion criteria
Inclusion criteria: Child or adolescent; both sexes; age range between 0 days and incomplete 15 years of age; indication for insertion of Peripherally Inserted Central Catheter equal to or greater than 2.8 French; child or adolescent scheduled for hospital follow-up
Exclusion criteria
Exclusion criteria: Children or adolescents or their guardians who request the withdrawal of their data from the research after the research data collection protocol has begun or at its end; children or adolescents allocated to the Experimental Group and for whom, by decision of the professional at the time of insertion of the peripherally inserted central catheter, it was not possible to use the SecurAcath® or Cyanoacrylate Glue devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of Peripherally Inserted Central Catheter displacement is expected for any type of displacement, which may be partial or total displacement. Partial displacement will be any change assessed by the number of centimeters displaced compared to the initial measurement and if total displacement is assessed, whether the catheter displaces and becomes peripheral or needs to be removed. It will be documented by radiography, clinical evaluation and monitoring during the data collection period through images | — |
Secondary
| Measure | Time frame |
|---|---|
| A lower rate of Central Catheter-Associated Bloodstream Infection is expected, as verified by laboratory-proven infection and professional evaluation;It is expected to find a lower incidence of skin impairment associated with the central catheter analyzed by the Central Venous Access Devices - Associated Skin Impairment (CASI) Algorithm. Complications will be defined as yes or no, and may be infection at the insertion site, skin injury, skin irritation and exudation (non-infectious);It is expected that there will be a reduction in pain assessed using three pain scales, according to the age group of the child or adolescent, classified as yes or no, and mild, moderate and severe. The scales will be the Revised Faces Pain Scale (FPS-R), the Newborn Pain Assessment Scale (NIPS) and the Revised Faces, Legs, Activity, Crying, Consolability Scale (FLACCr);It is expected to evaluate the satisfaction of the child or adolescent and guardian with the fixation devices and verified by a five-point Likert scale, which can be dissatisfied, somewhat satisfied, neither satisfied nor dissatisfied, satisfied and very satisfied;It is expected to evaluate the cost-benefit of fixation devices, calculated by adding up expenses and comparing between groups;It is expected to observe a longer dwell time of the peripherally inserted central catheter, verified by means of the time from insertion to the end of the research, calculated in hours and days.;It is expected to evaluate the satisfaction of professionals with the fixation devices related to the ease of insertion and removal and verified by a five-point Likert scale, which can be dissatisfied, somewhat satisfied, neither satisfied nor dissatisfied, satisfied and very satisfied | — |
Countries
Brazil
Contacts
Public ContactPatrícia Rocha
Universidade Federal de Santa Catarina
Outcome results
None listed