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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02932800
Other study ID # Mario2015
Secondary ID
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


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
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