Reduction of Complications Associated With Extraluminal PICC Management.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Miguel Servet
About this trial
The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation. A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up. Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications (first infection and second MARSI) associated with extraluminal device care with clorhexidine fixation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be over 18 years of age
accept participation in the study
independent patient in the care and management of activities of daily living
Disqualifiers
patient over 18 years of age
patient with functional or cognitive limitation
patient with mild, moderate or high level of dependence
patient does not accept to perform the study
Trial design
Design model
Parallel
Treatments tested in this trial
G2:PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days
Procedure/SurgeryPIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days
G3: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days
Procedure/SurgeryPIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: PIVC fixed with SecurAcath 15 DAYS G2Experimental treatment 1 intervention
Group C: PIVC fixed with SecurAcath and chlorhexidine 15 DAYS G3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
infections
Identify the type of frequency of care for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (less phlebitis, and bacteriemias) Reduction also of complications such as thrombosis, accidental withdrawals, obstruction. measurement of the various complications according to: number of associated complications per device according to intervention group
Time frame
Measurement follow-up until removal or 6 and 12 months after catheter implantationSecondary outcomes
1
other complications
trombosis, MARSI, accidental removal
Time frame
day 1, day 7, day 14, at 6 and 12 months after placement and start of the study of the device and at 12 months after the device is removed2
satisfaction
level of patient satisfaction related to various processes and frequencies of care use of a liker-type scale (1-10) to determine the level of overall satisfaction with the care and handling of the device
Time frame
day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removedOther outcomes
1
cost-benefit
Recognize the cost-effectiveness of each of the randomization groups included in the study. Measurement of direct and indirect costs of device care by study group, taking into account whether there are complications and the costs associated with them
Time frame
day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removed. at 6 months after placement and start of the study of the device and at 12 months after the device is removedLocations
Sponsors and contacts
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Fundacion Miguel Servet
Lead sponsor
Complejo Hospitalario de Navarra
Collaborator
Source ClinicalTrials.gov
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