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

Suture, Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02932800
• Other study ID #: Mario2015
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2016
• Last updated: October 12, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Universidade do Vale do Sapucai
• Contact: Mario Lucio Leal, MD
• Phone: 5535999427114
• Email: mariomedpa[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Suture, Complication

Intervention

Procedure:
• Fixation with "ballerina" technique and flip

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

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

Locations

Country	Name	City	State
Brazil	Mario Lucio Leal	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin evaluation	It will be evaluation, the presence of hyperemia or not	The evaluation will be on the third and fifth day after implantation	No
Other	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.	No
Primary	Changes in catheter fixation	traction, kicking off, fixing loss of the device	The evaluation will be on the third and fifth day after implantation	No