Central venous Access device SeCurement And Dressing Effectiveness in the ICU: the CASCADE ICU Trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000667516
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: Associate Professor Marion Mitchell
• Public title: Central venous Access device SeCurement And Dressing Effectiveness in the ICU: the CASCADE ICU Trial
• Scientific title: Randomised controlled trial of tissue adhesive, integrated securement products or external stabilisation devices versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in intensive care patients with non-tunnelled, percutaneous central venous access devices: the CASCADE ICU trial
• Date of first enrolment: 30/11/2015
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000667516.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: A/Prof Marion Mitchell

• Name: A/Prof Marion Mitchell

Key inclusion & exclusion criteria

Inclusion criteria: 1. Informed written consent
2. Non-tunnelled percutaneous CVAD to be inserted in ICU for clinical care for >24 hours

Exclusion criteria: 1. Peripherally inserted, tunnelled, dialysis, or pulmonary artery catheters;
2. Current bloodstream infection;
3. CVAD to be inserted through diseased, burned, scarred or hirsute skin;
4. Allergy to any study product;
5. Previous study enrolment in this admission

Age minimum: 16 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health service research

Central venous access device failure prior to completion of therapy;
Central venous access device failure prior to completion of therapy

Intervention(s)

Patients in this study have central venous access devices (CVADs) used in adult intensive care departments. Consenting patients will have their CVADs secured with one of the following randomly assigned dressings and securements:
Arm 1: Tissue Adhesive (TA) is a medical grade 'superglue'
(cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. Within this study it will be applied to the CVAD insertion site, and used in addition to a chlorhexidine-impregnated bordered polyurethane dressing and sutures.
Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic or self-gripping soft fasteners. SSD are used in addition to bordered polyurethane.
Arm 3: Integrated securement and dressing products which combine the durability and visibility of the transparent polyurethane, whilst including an absorbent pad and additional security via bordering. A chlorhexidine-impregnated disc and suture will also be used.
Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They are routinely used in conjunction with suture and are chlorhexidine impregnated.
The randomly allocated dressing will be applied until completion of therapy. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.

Primary Outcome(s)

CVAD failure: all-cause CVAD failure (composite of infection, occlusion, dislodgement, thrombosis, haematoma or breakage). Device failure is the outcome of importance to patients, with poor securement and dressing taking various pathways to the same endpoint – CVAD removal with requirement for a new CVAD insertion[CVAD removal]

Feasibility of a full efficacy trial, established by a composite analyses of: eligibility, recruitment, retention and attrition, protocol adherence, missing data, intervention acceptability and effect size estimates. The primary outcome for the full efficacy trial which requires and effect size estimate is all-cause CVAD failure. [Study completion]

Secondary Outcome(s)

Central line-associated bloodstream infection (CLABSI): A laboratory confirmed bloodstream infection (LCBSI) that is not secondary to an infection at another body site (NHSN criteria) (excludes Mucosal Barrier Injury LCBSI) with CVAD in place for >2 days when all elements of LCBI were first present together. Determined by blinded infectious disease specialist. [CVAD removal]

CVAD & 1st securement-dressing dwell time: hours from insertion/application until removal[CVAD failure, dressing failure]

Dislodgement: Partial –change in CVAD length from hub to tip, as measured by marking closest to hub, or CVAD removal because tip is no longer in superior vena cava (diagnosed by xray/leakage from site on injection). Complete: CVAD body completely leaves the vein. [CVAD removal]

Patient and staff satisfaction: using 0-10 NRS and interview[Dressing application and CVAD removal]

Thrombosis: Development of thrombosed vessel (partial or complete) at the CVAD site diagnosed on ultrasound as requested by the treating clinician for suspected thrombosis[CVAD removal]

Local infection: Purulent phlebitis confirmed with a positive (>15cfu) CVAD tip culture, but with negative or no blood culture [CVAD removal]

Occlusion Partial: 1 or more lumens cannot be flushed and/or aspirated, or resolved after anticoagulant dwell. Complete: all lumens cannot be flushed and/or aspirated despite anticoagulant dwell.[CVAD removal]

Securement-dressing failure: Replacement < 7 days for loose, missing, bloodstained, diaphoresis or secretion soaked dressings [7 days post application]

CVAD strength: tensile strength post CVAD removal[CVAD removal]

Costs: all healthcare utilisation costs; composite of dressings, complications.[Study completion]

CVAD breakage: Visible split in CVAD material diagnosed by leakage or radiographic evidence of extravasation from a portion of the CVAD into tissue[CVAD removal]

All bloodstream infections: Any positive blood culture that meets the CDC NHSN criteria for Laboratory Confirmed Bloodstream Infection (LCBSI), excluding mucosal barrier-LCBSI [CVAD removal]

Haematoma around CVAD site: Significant haematoma / bruise around CVAD site[CVAD removal]

Safety endpoints: Skin rash, skin tears, blisters, pruritis, local or systemic allergic reaction.[CVAD removal]

Primary bloodstream infections: positive blood culture and clinical signs or symptoms of localized infection at the CVAD site, but no other infection can be found[CVAD removal]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Centre for Health Practice Innovation; Menzies Health Institute Queensland

Intensive Care Foundation

Ethics review

Status: Approved
Approval date:
Contact:

Royal Brisbane and Women's Health Service