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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02932800
Enrollment
62
Registered
2016-10-13
Start date
2015-11-30
Completion date
2016-12-31
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suture, Complication

Keywords

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

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.

Interventions

PROCEDUREFixation with ballerina technique and flip
PROCEDUREHabitual Fixation

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

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

Sponsors

Universidade do Vale do Sapucai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 ;

Design outcomes

Primary

MeasureTime frameDescription
Changes in catheter fixationThe evaluation will be on the third and fifth day after implantationtraction, kicking off, fixing loss of the device

Other

MeasureTime frameDescription
Skin evaluationThe evaluation will be on the third and fifth day after implantationIt will be evaluation, the presence of hyperemia or not
Local CultureWill be collected a local swab at the third and fifth day after implantation.The material will be seed at least 6 hours, and analyzed after 48h incubation

Countries

Brazil

Contacts

Primary ContactMario Lucio Leal, MD
mariomedpa@yahoo.com.br5535999427114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026