Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568670
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Patricia Vendramim, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Phlebitis Other: clinical signs Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: according to clinical signs
removal the peripheral catheter according to clinical signs
Other: clinical signs
to remove the peripheral venous catheter according clinical signs

No Intervention: sistematically every 96 hours
removal the peripheral catheter every 96 hours



Primary Outcome Measures :
  1. presence of phlebitis [ Time Frame: 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 ]
    phlebitis (phlebitis/1000 peripheral venous catheters-day), stratified by severity.


Secondary Outcome Measures :
  1. presence of other complications related peripheral intravenous (PIC) therapy in the two groups [ Time Frame: 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 ]
    complications (event/1000 peripheral venous catheters-day)

  2. time interval for peripheral intravenous catheter (PIC) changes [ Time Frame: 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 ]

    Through these measures:

    • length of stay in hours / avp-day * 1000
    • length of stay in hours / patient

    From catheter fixation, during the indwell time of the catheter, until the removal of it.


  3. total number of peripheral intravenous catheter (PIC) [ Time Frame: After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days ]

    Total number of peripheral intravenous catheter (PIC) used in the two groups. Through these measures:

    • number of PIC re-inserted / patient
    • number of PIC re-inserted / avp-day * 1000
    • number of venous punctures to obtain access / patient

  4. Cost [ Time Frame: during the hospitalization, in average 5 to 6 days ]

    . Cost of 30 minutes of professional time for peripheral intravenous puncturing (PIP).

    • Cost of inputs for each insertion - soap for cleaning, examination gloves, pre-filled syringe with saline, alcohol swab, PIC, intermediate type extension y, two valve connectors, fixture and transparent semi-permeable membrane covering polyurethane.
    • Cost 10 minutes from time professional (practical nurse) for removal.
    • Cost of inputs to remove the PIC - alcohol swab and anti-hemorrhagic coverage.
    • Cost of daily patient hospitalization related to the catheter dwell time.

  5. The experience of the patient [ Time Frame: the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days ]
    applying a questionnaire of assessment of the experience of the patient in use of peripheral venous catheter at the end of admission, wich was elaborated by the author and validated by expert judges. Principal contents: Information and education: guidance on research and care given peripheral IT Physical comfort: pain or discomfort procedures Emotional support: considered in this study as trust / security transmitted and perceived Respect for patient preferences: flexibility to accept small patient preferences Involvement of family and friends: identify the participation of people significant to patient and allow shared decision Continuity and transition: if care is independent continuous service location within the institution General impressions: courtesy and availability of staff Overall satisfaction: at the end the experience was satisfying Complaints: originated by dissatisfaction reasons Fidelity: creation of the trust, return and referral to another service



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568670


Locations
Layout table for location information
Brazil
Samaritano Hospital
Sao Paulo, São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Patricia Vendramim, MsC, PhD student, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02568670    
Other Study ID Numbers: 15849513.2.0000.5487
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis