Clinical trial NCT02568670: Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study
Official title: Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phlebitis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 1305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a two-centers, open label, prospective, randomized, noninferiority controlled trial with cost-effectiveness analysis to verify if is non inferior to remove peripheral intravenous catheter according to clinical signs in relation to every 96 hours.

Detailed description: The care practice standards related to infusion therapy (IT) are stipulated and regulated by US institutions, such as the Infusion Nurses Society (INS) and the Center for Disease and Control (CDC), and, in Brazil, by the Brazilian National Health Surveillance Agency (ANVISA). Within this topic, the investigators can mention peripherally administered IT through peripheral intravenous catheters (PIC) as the most used one, since this is less complex and less invasive, and it offers a lower risk of severe complications compared to central line IT.

PIC placement, maintenance and removal procedures are not free of complications, and in order to prevent them, regulatory agencies publish formal recommendations. One of these refers to the time the PIC remains at the same site (residence time), which has been determined to be 96 hours for the adult population, i.e., it should be removed and punctured again at another site, systematically, even if not showing any inflammatory sign within 96 hours.

Following literature review, one can see that these recommendations are based on limited evidence, and supported by data from old studies. For this reason, the investigators discuss if employing a systematic and elective change procedure for adults would be the best option, as the investigators have taken some aspects into consideration, such as: Patient safety - The PIC dwell time at the placement site, as shown by research results, has increased throughout the decades to 24, 48, 72, and 96 hours. If the PIC change is performed on a child who, theoretically, is a less immune-competent patient as compared to adults, this is performed according to clinical signs, then the investigators can conclude that adopting the same procedure for adults would be safe. Peripheral venous depletion - Logic leads us to consider that the less the investigators puncture a patient, more access is available, and less outcomes with IT-specific complications occur. Patient satisfaction - With reduced exposures to painful and invasive events, the patient will also benefit from it. Few patients refrain from showing dissatisfaction when the PIC is to be placed again electively. Quality - Producing scientific evidence and adopting the best practices in hospital environments is practicing quality. Economic aspects - If these PIC changes were less frequent, they would necessarily imply less spending with inputs and devices, as well as less time spent by the team performing the procedure, which represents less cost and workload. Occupational safety - Studies show an estimated relationship between the occurrence of an accident with biological material and performing invasive procedures. Reducing the number of punctures performed by a professional, in addition to decreasing the workload, may reduce the exposure to risk and accidents.

Research studies carried out mostly in Australia aim at showing that the systematic PIC removal and change do not bring benefits, when compared to change based on clinical manifestations. However, a systematic review study in 2010 did not find conclusive evidence, and suggested the development of other projects in several regions, of different natures and realities, so as to further mature the hypothesis. To support this, the INS has also formally stated that this theme is a research priority at this time.

Eligibility criteria: Inclusion Criteria:

* any medical diagnosis, except for those stated as exclusion criteria, and
* with a therapeutic proposal of undergoing the therapy for at least 96 hours, or four days;
* agree with the proposals expressed in the Informed Consent Form (ICF); and
* have a catheter that has not been placed at the ER.

Exclusion Criteria:

* medical diagnosis of immunosuppression or receiving immunosuppressants;
* using more than one peripheral catheter simultaneously;
* refusing to take part in the research.

Primary outcomes:
measure: presence of phlebitis
timeFrame: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
Secondary outcomes:
measure: presence of other complications related peripheral intravenous (PIC) therapy in the two groups
timeFrame: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
measure: time interval for peripheral intravenous catheter (PIC) changes
timeFrame: For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
measure: total number of peripheral intravenous catheter (PIC)
timeFrame: After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days
measure: Cost
timeFrame: during the hospitalization, in average 5 to 6 days
measure: The experience of the patient
timeFrame: the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samaritano Hospital
state: São Paulo
Study officials:
References:
citation: Vendramim P, Avelar AFM, Rickard CM, Pedreira MDLG. The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 hours: A randomized, controlled, non-inferiority trial. Int J Nurs Stud. 2020 Jul;107:103504. doi: 10.1016/j.ijnurstu.2019.103504. Epub 2020 Jan 11.