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

NCT ID: NCT02932800

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

"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 .

Group Type: ACTIVE_COMPARATOR

Fixation with "ballerina" technique and flip

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Habitual Fixation

Intervention Type: PROCEDURE

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

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

Intervention Type: OTHER

Interventions

Fixation with "ballerina" technique and flip

Intervention Type: PROCEDURE

Habitual Fixation

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

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

Eligibility Criteria

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 ;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Vale do Sapucai

OTHER

Sponsor Role: lead

Responsible Party

Mário Lúcio Marques Leal

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mario Lucio Leal

Pouso Alegre, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mario Lucio Leal, MD

Role: CONTACT

mariomedpa@yahoo.com.br

5535999427114

Facility Contacts

Mario Lucio Leal, MD

Role: primary

mariomedpa@yahoo.com.br

55 35 999427114

Other Identifiers

Mario2015

Identifier Type: -

Identifier Source: org_study_id