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

NCT02568670 | Completed DMC

• 1 other identifier: 15849513.2.0000.5487
• Study Type: interventional
• Target: 1,305
• Locations: 1 country
• Sites: 1

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.

Conditions

Phlebitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• presence of other complications related peripheral intravenous (PIC) therapy in the two groups

  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

• time interval for peripheral intravenous catheter (PIC) changes

  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

• total number of peripheral intravenous catheter (PIC)

  After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days

• Cost

  during the hospitalization, in average 5 to 6 days

• The experience of the patient

  the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days

Study Arms (2)

according to clinical signs

EXPERIMENTAL

removal the peripheral catheter according to clinical signs

Other: clinical signs

sistematically every 96 hours

NO INTERVENTION

removal the peripheral catheter every 96 hours

Interventions

clinical signs OTHER

to remove the peripheral venous catheter according clinical signs

according to clinical signs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Samaritano Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32334176 DERIVED

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC, PhD student

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: October 6, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

BR (1)