Controlling device Occlusion by needleless ConnectOr design. A pilot randomised control trial (COCOA Trial)

A pilot randomised controlled trial to compare incidence of peripheral venous catheter failure with the use of neutral versus negative needleless connectors (COCOA Trial)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001091190

Acronym

COCOA Trial

Enrollment

200

Registered

2019-08-08

Start date

2020-03-03

Completion date

2020-09-01

Last updated

2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access device to provide intravenous treatment to hospitalised patients. A needleless connector (NC) allows a PVC to be connected to an administration set or syringe without the use of needles. Many hospitals (including the Royal Brisbane and Women’s Hospital) use a negative pressure NC. This device, on the completion of access or flushing, creates a negative displacement allowing a small amount of blood to move back into the catheter. Manufacturers have recently created complex NCs comprised of mechanical valves with neutral pressure (no fluid displacement). This randomised controlled trial will test the efficacy, cost effectiveness and acceptability to patients of a neutral pressure NC. Sample: 200 adult patients in the cancer care, general medical and surgical wards of the RBWH. Primary outcomes: (1) feasibility (2) device failure.

Interventions

Participants in this study will have peripheral venous catheters (PVC) inserted in an adult tertiary hospital. Consenting patients will have their PVC connected to one of the following to randomly assigned needleless connectors: Arm 1 (Intervention): MicroClave (neutral pressure) needleless connector, attached prior to the first device access. Arm 2 (Control): Smartsite (negative pressure) needleless connector, attached prior to the first device access. Patients will be monitored daily to ensure protocol adherence and assess for any complications. The randomly allocated connector will be applied from device insertion (by the inserter - either a Research Nurse or treating clinician) and replaced as clinically indicated (by treating clinicians) until removal of device. PVC insertion site (eg. hand, forearm) will be selected by the Research Nurse or treating clinician based on site and vein appropriateness. Duration of treatment (PVC dwell) will be between 1-29 days (approximately).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient requires a PVC for greater than 24 hours 2. PVC has not been insitu greater than 2 hours 3. The PVC has not yet been accessed for treatment 4. Equal to or more than 18 years of age (no upper limit) 5. Able to provide written informed consent.

Exclusion criteria

• Current blood stream infection (within 48 hours of study entry, with the exclusion of a single common skin contaminant as per NHSN) • Non-English speaker without interpreter • Previous enrolment in this study • On a palliative care pathway and/or receiving critical care treatment.

Outcome results