The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection

Not Applicable

Completed

• Conditions: Surgery; Haematologic Disease; Multiorgan Failure
• Interventions: Procedure: CHG technique; Procedure: HMG technique

• Registration Number: NCT03875352
• Lead Sponsor: University Hospital Ostrava

Brief Summary

Assessing the impact of the nursing technique applied at the insertion site of the central venous catheter using hydrophilic methacrylate gel (HMG) and 2% Chlorhexidine (CHG) upon the incidence of inflammatory complications when treating the surrounding of the central venous catheter.

Detailed Description

The study was a prospective and randomized clinical trial. The study was performed at two departments of the University Hospital Ostrava.

The design and performance of the study were approved by the Ethics Committee of the University Hospital Ostrava.

The patients indicated for insertion of central venous catheter (CVC) were informed about the possible nursing techniques applied at the insertion site of the central venous catheter, participation in the study was conditioned with signing a written informed consent. The study evaluated the superiority of a new procedure in providing nursing care for patients with CVC.

Basic patient characteristics were observed and recorded according to the protocol of the study (age, sex, diagnosis), the number of days with CVC inserted, type of dressing, APACHE II score, the presence of neutropenia and the final score of assessment of local signs of inflammation, which was defined as follows:

0 points = No reddening

1. point = Reddening below 2 mm in diameter around the incision

2. points = Reddening below 5 mm in diameter around the incision

3. points = Reddening exceeding 5 mm in diameter around the incision

4. points = Purulent secretion, swelling, pain

5. points = Catheter sepsis The investigators also recorded the day when the first signs of local infection were observed.

The obtained results were evaluated with standard statistical techniques (Chí-quadrate test, Fisher's exact test).

Upon inserting CVC, the type of draping was recorded (small, middle, large), and the cannulated vein (vena subclavia, left and right, vena jugularis interna, left and right, vena femoralis, left and right). A smear was obtained from around the incision site in all patients after insertion and after extraction; the smears were sent for microbiology cultivation and determination of sensitivity to antibiotic therapy. Changing of the dressings was performed in accordance with standard operating procedures of the University Hospital Ostrava. The CVC was attended under aseptic conditions, using sterile material. Surrounding of CVC was mechanically cleaned and disinfected using 2% chlorhexidine for disinfection of the skin, let to dry, and semipermeable foil was placed at the site, containing chlorhexidine gluconate. The dressing was identified with a date when it was applied. This was left in situ for 3-4 days, and the procedure was repeated.

The patients were randomized into two study groups:

1. HMG Group - the patients were treated with 2% chlorhexidine for skin disinfection, HMG and transparent foil

2. CHG Group - the patients were treated with 2% chlorhexidine for skin disinfection and dressing with CHG The randomization procedure further divided the patients into two study arms

1. Neutropenia Group (defined as the number of neutrophil granulocytes below 1x109/l 2. No-neutropenia Group (with a normal number of neutrophil granulocytes

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Age over 18 years
• Patients with CVC
• Hospitalization at ICU

Exclusion Criteria

• Allergy to HMG
• Allergy to transparent foil
• CVC insertion shorter than 3 days
• Strong bleeding from CVC insertion site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No neutropenia patients	CHG technique	Patients with no neutropenia were treated using the CHG and HMG technique.
No neutropenia patients	HMG technique	Patients with no neutropenia were treated using the CHG and HMG technique.
Neutropenia patients	CHG technique	Patients with neutropenia were treated using the CHG and HMG technique.
Neutropenia patients	HMG technique	Patients with neutropenia were treated using the CHG and HMG technique.

Primary Outcome Measures

Name	Time	Method
Local signs of inflammation	3 days at minimum, up to 15 days	The local signs of inflammation were observed in both study arms and both interventions, and were assessed according to the scoring system described in detail description.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia