Randomized Clinical Trial on the Role of Port Protectors for the Management of Venous Central Line Catheter in Respiratory Semi-intensive Care Unit.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 132
- Primary Endpoint
- Rate of CLABSIs.
Study Overview
Brief Summary
Central Line-Associated BloodStream Infections (CLABSIs) are responsible for many deaths in the United States annually.
Several collaboratives have demonstrated the preventability of these infections.
Educational interventions decrease rates of CLABSIs. In addition to training, education, and surveillance, important prevention practices include the use of chlorhexidine skin antiseptics and maximal sterile barrier precautions at catheter insertion. Other maintenance practices include hand hygiene before handling catheters or catheter sites, chlorhexidine for skin antisepsis with dressing changes, and disinfecting catheter hubs or injection ports with an appropriate agent before accessing the catheter.
Antimicrobial catheter locks, including nonantibiotic antiseptic locks (such as alcohol or trisodium citrate), have also demonstrated some success in reducing CLABSIs. In particular, alcohol-impregnated port protectors and needleless neutral pressure connectors significantly reduced rates of CLABSIs.
Respiratory semi-intensive care units (RICUs) usually work as "step-up" units within acute care hospitals to manage patients with respiratory failure with non-invasive ventilation. These units may provide multidisciplinary rehabilitation and serve as a bridge to home-care programs or long-term care facilities. Some of these RICUs may work also as "step down" units for difficult to wean patients.
The investigators performed a single-centre prospective randomized clinical trial with the aim to assess the efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CLABSIs. Moreover, the investigators evaluated the effects of previously mentioned interventions on rates of CVC colonizations and contaminated blood cultures.
Detailed Description
The study enrolled patients admitted to RICU and it lasted 18 months. Patients were enrolled when a CVC: 1) was placed during hospitalization in RICU; 2) had already been placed at admittance and patients didn't show signs of systemic inflammatory response syndrome (SIRS) during first 48h from admission to RICU; 3) had already been placed at admittance without evidence of microbiologic contamination of blood cultures.
Each patient gave written informed consent. Patients enrolled underwent blood cultures sampling whenever they showed SIRS signs.
SIRS is defined as 2 or more of the following variables: 1) fever of more than 38°C (100.4°F) or less than 36°C (96.8°F), 2) heart rate of more than 90 beats per minute, 3) respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg, 4) abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature [band] forms). Septic shock was defined as sepsis associated with organ dysfunction and persistent hypotension despite volume replacement.
According to international guidelines, blood cultures were collected simultaneously from both central line and peripheral blood. So doing, five different mutually exclusive conditions were identified: 1) significant different time to positivization of blood cultures (at least 2 hours) between central line sample and peripheral sample (sepsis related to CVC - CLABSIs); 2) not significant different time to positivization of blood cultures (sepsis not related to CVC); 3) positive blood cultures from central line sample and negative from peripheral one (CVC colonization); 4) negative blood cultures from central line sample and positive from peripheral one (contaminated blood cultures); 5) negative blood cultures from both peripheral and central line samples (SIRS not sustained by sepsis). CVCs were removed when conditions 1 and 3 occurred. Catheter tips were collected and prepared for subsequent microbiological analysis and identified microbial species have been reported.
Each catheter was designated by type of vessel used (peripheral versus central); site of insertion (subclavian, femoral, internal jugular, peripheral, and Peripherally Inserted Central Catheter [PICC]).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CVC placed during hospitalization in RICU;
- •CVC already placed at admittance without signs of systemic inflammatory response syndrome (SIRS) during first 48h from admission to RICU;
- •CVC already placed at admittance without evidence of microbiologic contamination of blood cultures;
- •written informed consent.
Exclusion Criteria
- •CVC placed during hospitalization in other Hospital;
- •CVC placed during hospitalization in other Unit with signs of systemic inflammatory response syndrome (SIRS) during first 48h from admission to RICU and / or evidence of microbiologic contamination of blood cultures.
Arms & Interventions
CVC managed by healthcare workers
Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations.
Intervention: Training and retraining to GAVECELT "bundle" recommendations (Behavioral)
CVC managed by healthcare workers plus port protector
Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations with the aid of port protector devices.
Intervention: Training and retraining to GAVECELT "bundle" recommendations plus port protector (Device)
Outcomes
Primary Outcomes
Rate of CLABSIs.
Time Frame: Through study completion, an average of 18 months.
Efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CLABSIs.
Secondary Outcomes
- Rate of CVC colonizations(Through study completion, an average of 18 months.)
- Rate of contaminated blood cultures.(Through study completion, an average of 18 months.)
Investigators
Riccardo Inchingolo
Principal Investigator
Catholic University of the Sacred Heart