Port Protectors for Prevention of CLABSIs in Respiratory Semi-intensive Care Unit

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.

Conditions

• Central Line-associated Bloodstream Infection (CLABSI)

Interventions

DEVICE

Training and retraining to GAVECELT "bundle" recommendations plus port protector

Physicians and nurses of RICU have been trained and retrained to GAVECELT "bundle" recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed. After the first training meeting, the use of Curos® Disinfecting Port Protector for needleless valves port-protector has been introduced.

BEHAVIORAL

Training and retraining to GAVECELT "bundle" recommendations

Physicians and nurses of RICU have been trained and retrained to GAVECELT "bundle" recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed.

Sponsors & Collaborators

• Catholic University of the Sacred Heart

  lead OTHER

Principal Investigators

• Riccardo Inchingolo, MD, PhD · Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart

• Giuseppe M Corbo, MD, Prof. · Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-09-30

Completion

2014-09-30