Midline Catheters Versus Peripheral Catheters in Internal Medicine Unit

August 20, 2022 updated by: Elena Chover Sierra, Hospital General Universitario de Valencia

Análisis de la utilización de Los catéteres Intravenosos periféricos de Linea Media Frente a Los catéteres Intravenosos periféricos Convencionales en el Servicio de Medicina Interna

The study aims to evaluate the rate of complications and the duration of cannulation of a midline intravenous catheter compared to a short peripheral catheter in patients hospitalized in an Internal Medicine service of a Spanish hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, longitudinal experimental study is designed, which will allow comparisons to be made between the results obtained in the experimental group and the control group.

The study will be carried out in the Internal Medicine and medium and long stay unit of the CHGUV, during the period of time necessary to complete the required sample size, which has finally been established at six months.

When the patient is admitted to our unit, a number is assigned from the admission service, based on their admission order; this number will serve for subsequent random assignment to one another group. In this case, the use of a website to generate said numbers is proposed.

Using established procedures for the generation of random numbers, the numbers that correspond to the subjects that are going to be part of each of the groups will be identified.

The list of random numbers that will make up the experimental group has been prepared previously by the Internal Medicine Unit secretary and will be known by the person who will carry out the placement of the midline catheter (two nurses from the unit trained in the placement and handling of this type of device, who will also be those in charge of training the rest of the staff).

The list will be reviewed daily in the morning shift, and those patients who have not given their informed consent will be eliminated, those in whom, due to their pathology, a brief admission is expected or patients who are in a terminal or palliative care situation, in those who consider the step of treatment to the subcutaneous route as the best option.

The informed consent to participate in the study will be given to the patient and/or relatives at the time of admission, also informing them that the next morning those responsible for the study will explain the object of the study in more depth and answer their questions.

Before the third day after admission, in the morning shift, the peripheral catheters will be reviewed and replaced by another peripheral catheter or by a midline catheter depending on the group to which the patient has been assigned. In case of being a patient assigned to the experimental group, the midline catheter will be placed by personnel trained for it.

The procedures for inserting and maintaining the catheters are already established in the unit and will be those that will be followed during the study, depending on the type of catheter; The care in the insertion and maintenance of midline catheters does not differ from the care of peripherally inserted central catheters, since they require a sterile technique; therefore, although the insertion of the midline catheters will be done by the selected investigators, maintenance will be performed by the unit's staff, following, as we have indicated, the procedures already established.

When the patient requires a change of venous access for whatever reason, it will be replaced by the same type of catheter (midline or conventional catheter) and the necessary information will be added to the information record sheet.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients included were those who were hospitalized in the Internal Medicine Service of the Consorcio Hospital General Universitario de Valencia who needed intravenous therapy and who had signed the Informed Consent for placement of a midline at the time of the change of the PIVC placed in the emergency unit.

Exclusion Criteria:

  • Those with a forecast hospitalization of less than one week, those who were receiving palliative or symptomatic treatment, those who were carriers of a CVC or those who had presented difficulty in venous access with midline after two consecutive attempts were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midline Catheter
Midline catheter insertion
Device: Midline insertion
Midline catheter insertion
No Intervention: Peripheral intravenous cannulation (PIVC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of canalization
Time Frame: Four weeks
Days of catheter stay
Four weeks
Number of punctures
Time Frame: Four weeks
Number of times a catheter is inserted
Four weeks
Phlebitis
Time Frame: Four weeks
Presence of catheter related phlebitis
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 20, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 20, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HGUValencia_midline

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: All study information can be requested via email.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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