Clinical trial NCT02932800: Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques
Official title: Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suture, Complication
Keywords: Catheters
Vascular Access Devices
Suture Techniques
microbiota
Blood Circulation
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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 ;

Primary outcomes:
measure: Changes in catheter fixation
timeFrame: The evaluation will be on the third and fifth day after implantation
Secondary outcomes:
Other outcomes:
measure: Skin evaluation
timeFrame: The evaluation will be on the third and fifth day after implantation
measure: Local Culture
timeFrame: Will be collected a local swab at the third and fifth day after implantation.
Locations:
city: Pouso Alegre
country: Brazil
facility: Mario Lucio Leal
state: Minas Gerais
Study officials:
References: