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

NCT02932800 | Unknown DMC

• 1 other identifier: Mario2015
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suture, Complication

Keywords

Catheters; Vascular Access Devices; Suture Techniques; microbiota; Blood Circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin evaluation

  The evaluation will be on the third and fifth day after implantation

• Local Culture

  Will be collected a local swab at the third and fifth day after implantation.

Study Arms (2)

"Ballerina" associated with flap fixation

ACTIVE COMPARATOR

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

the usual fixation technique

ACTIVE COMPARATOR

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.

Procedure: Habitual Fixation; Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture

Interventions

Fixation with "ballerina" technique and flip PROCEDURE

"Ballerina" associated with flap fixation

Habitual Fixation PROCEDURE

Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture

the usual fixation technique

Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture OTHER

"Ballerina" associated with flap fixation; the usual fixation technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ) ;

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Mario Lucio Leal

Pouso Alegre, Minas Gerais, 37550-000, Brazil

RECRUITING

MeSH Terms

Interventions

CASP8 and FADD-Like Apoptosis Regulating Protein; Culture Techniques

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins; In Vitro Techniques; Investigative Techniques

Central Study Contacts

Mario Lucio Leal, MD

CONTACT

5535999427114; mariomedpa@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

BR (1)