Phlebitis Clinical Trial
— ResPeCtOfficial title:
Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)
Verified date | March 2018 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1305 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Samaritano Hospital | Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence of phlebitis | phlebitis (phlebitis/1000 peripheral venous catheters-day), stratified by severity. | 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 | presence of other complications related peripheral intravenous (PIC) therapy in the two groups | complications (event/1000 peripheral venous catheters-day) | 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 | time interval for peripheral intravenous catheter (PIC) changes | 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. |
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 | total number of peripheral intravenous catheter (PIC) | 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 |
After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days | |
Secondary | Cost | . 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. |
during the hospitalization, in average 5 to 6 days | |
Secondary | The experience of the patient | 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 | the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days |
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