Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques

Context: The central venous catheter is used in intensive care units for several indications, including the administration of drugs with sclerosis potential, infusion solutions and hemodynamic monitoring. It can be accessed by per cutaneous puncture using the Seldinger technique, which is an extremely common procedure in intensive care units. The displacement or accidental removal of central venous catheter caused by poor fixation have received little attention, but imply potentially life threatening caused by the complications which can result from the removal of the catheter and the need for reinsertion. Among these complications, can mention the interruption of vital therapies (inotropic and vasopressor drugs) and hemorrhagic shock. In fixing the catheter, the literature is not sufficient to assess whether sutures, staples or tapes are associated with a higher risk of infections. Objective: To compare the efficiency in fixing the short stay central venous catheter using the "Ballerina" technique associated with flap fixation to the usual fixation technique and to observe differences in colonization of microorganisms on the device insertion site. Methods: The investigators propose an individual study, analytical, intervention, longitudinal, prospective, controlled clinical trial and randomized to be developed in the Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio Clinical Hospital in The University of Sapucaí Valley and Intensive Care Unit Adult Clinical and Surgical of The Hospital e Maternity Santa Paula. After admission of the patient in the Intensive Care Unit and obtaining informed consent and informed, with indication of the short stay central venous catheter, the patient will be allocated through a table of random numbers for the groups: Habitual Fixation (n = 31) and Fixation with "ballerina" technique and flip (n = 31). The participants will evaluate fixation efficiency and colonization of the device's insertion site.

Study Overview

• Status: Unknown
• Conditions: Suture, Complication
• Intervention / Treatment: Procedure: Fixation with "ballerina" technique and flip; Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture; Procedure: Habitual Fixation

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550-000
      • Recruiting
      • Mario Lucio Leal
      • Contact: Mario Lucio Leal, MD; Phone Number: 55 35 999427114; Email: mariomedpa@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with indication for the use of central venous catheters ;
• Both genders ;
• Age greater than 18 years;
• Admitted to the intensive care unit;
• Informed Consent signed ( by the patient or family ) ;

Exclusion Criteria:

• Device repositioning Need for abnormal pathway or malposition after installation;
• No more indication of the central venous catheter use before the minimum period of 03 days ;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "Ballerina" associated with flap fixation; The catheter is anchored to the skin begins by a point "U" around the catheter insertion site and followed by a series of woven points around the catheter , commonly referred to as " node dancer " to pass the wires on each side of the orifices located at the catheter distal flaps and hold three consecutive nodes . Then, the clamping is carried out of the catheter to the skin by means of a simple point and hold three consecutive nodes in each lateral hole of the fastening flap while leaving, between the fastening flap and the puncture site a space 2 cm distance for viewing the ostium .	Procedure: Fixation with "ballerina" technique and flip; Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture
Active Comparator: the usual fixation technique; The catheter is attached to the skin with a simple point and holding three we row on each side hole fixing fin while leaving, between the fastening flap and the puncture site , an area of 2 cm away for viewing ostium . The catheter is anchored to the skin by a simple point and holding three consecutive us in each hole of the side flap in the distal region.	Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture; Procedure: Habitual Fixation; Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in catheter fixation	traction, kicking off, fixing loss of the device	The evaluation will be on the third and fifth day after implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin evaluation	It will be evaluation, the presence of hyperemia or not	The evaluation will be on the third and fifth day after implantation
Local Culture	The material will be seed at least 6 hours, and analyzed after 48h incubation	Will be collected a local swab at the third and fifth day after implantation.

Collaborators and Investigators

• Sponsor: Universidade do Vale do Sapucai

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 4, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: microbiota; Catheters; Vascular Access Devices; Suture Techniques; Blood Circulation
• Other Study ID Numbers: Mario2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED