Suture, ComplicationNCT02932800
Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques
A study testing Fixation with "ballerina" technique and flip, Habitual Fixation and Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture in people with Suture, Complication, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suture, Complication
- What is being tested?
- Fixation with "ballerina" technique and flip, Habitual Fixation and Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ) ;
Who cannot join
- 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 ;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mario Lucio Leal
Pouso Alegre, Minas Gerais, 37550-000
Mario Lucio Leal, MD, 55 35 999427114, mariomedpa@yahoo.com.br
About this study
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
- Being tested
- Fixation with "ballerina" technique and flip, Habitual Fixation, Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture
- Keywords
- Catheters, Vascular Access Devices, Suture Techniques, microbiota, Blood Circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation with "ballerina" technique and flipProcedure or surgery
Habitual FixationProcedure or surgery
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 cultureOther
| Study group | Role | What they receive |
|---|---|---|
| "Ballerina" associated with flap fixation | Active comparator | 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 . Receives: Procedure: Fixation with "ballerina" technique and flip; Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture |
| the usual fixation technique | Active comparator | 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. Receives: Procedure: Habitual Fixation; Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in catheter fixation
traction, kicking off, fixing loss of the device
Measured: The evaluation will be on the third and fifth day after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture, ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mário Lúcio Marques Leal, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932800
- Sponsor's protocol ID
- Mario2015
- Status last verified
- Oct 2016
- First submitted
- 4 Sep 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixing the Short Stay Central Venous Catheter: Comparison of Two Techniques
- ClinicalTrials.gov ID
- NCT02932800
- Acronym / sponsor ID
- Mario2015
- Conditions
- Suture, Complication
- Keywords
- Catheters, Vascular Access Devices, Suture Techniques, microbiota, Blood Circulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Ballerina" associated with flap fixation | Active comparator | Procedure: Fixation with "ballerina" technique and flip, Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and cultureThe 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 . |
| the usual fixation technique | Active comparator | Procedure: Habitual Fixation, Other: Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and cultureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 ) ;
Key exclusion criteria (2 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation with "ballerina" technique and flip | Procedure or surgery | "Ballerina" associated with flap fixation |
| Habitual FixationEvaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture | Procedure or surgery | the usual fixation technique |
| Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture | Other | "Ballerina" associated with flap fixation, the usual fixation technique |
Primary outcome
Changes in catheter fixation
Time frame: The evaluation will be on the third and fifth day after implantation
traction, kicking off, fixing loss of the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation with "ballerina" technique and flip, Habitual Fixation and Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture in people with Suture, Complication, run by Universidade do Vale do Sapucai at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Lucio Leal, MD (5535999427114, mariomedpa@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in catheter fixation (time frame: The evaluation will be on the third and fifth day after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.