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

NCT03486093 | Completed

• 1 other identifier: 5664/13
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Line-associated Bloodstream Infection (CLABSI)

Keywords

Venous central catheter; Central line-associated bloodstream infections; Port protector; Respiratory semi-Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Rate of CLABSIs.

  Efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CLABSIs.

  Through study completion, an average of 18 months.

Secondary Outcomes (2)

• 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.

Study Arms (2)

CVC managed by healthcare workers

EXPERIMENTAL

Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations.

Behavioral: Training and retraining to GAVECELT "bundle" recommendations

CVC managed by healthcare workers plus port protector

EXPERIMENTAL

Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations with the aid of port protector devices.

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

Interventions

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

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.

Also known as: Curos® Disinfecting Port Protector for needleless valves port-protector (CUROS, 70% isopropyl alcohol-impregnated, Ivera Medical, San Diego, California, US).

CVC managed by healthcare workers plus port protector

Training and retraining to GAVECELT "bundle" recommendations BEHAVIORAL

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.

CVC managed by healthcare workers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Related Publications (1)

• Inchingolo R, Pasciuto G, Magnini D, Cavalletti M, Scoppettuolo G, Montemurro G, Smargiassi A, Torelli R, Sanguinetti M, Spanu T, Corbo GM, Richeldi L. Educational interventions alone and combined with port protector reduce the rate of central venous catheter infection and colonization in respiratory semi-intensive care unit. BMC Infect Dis. 2019 Mar 4;19(1):215. doi: 10.1186/s12879-019-3848-z.

  PMID: 30832598 DERIVED

Study Officials

• Riccardo Inchingolo, MD, PhD

  Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Giuseppe M Corbo, MD, Prof.

  Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients have been randomized into two groups: 1. patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations. 2. Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations with the aid of port protector devices.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 3, 2018
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share