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

INTERVENTION: 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). CONDITION: Peripheral intravenous catheter failure; ; Peripheral intravenous catheter failure Public Health ‐ Health service research PRIMARY OUTCOME: All‐cause device failure. This is defined as premature device removal before the end of therapy because of: phlebitis; infiltration/extravasation; occlusion (including leakage); local or catheter related bloodstream infection. ; ; These will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until device removal. ; Infection outcomes will be assessed from the time of device insertion to 48 hours after device removal.] The feasibility of conducting an adequately powered RCT as established by the following criteria: ; • Eligibility (equal to or more than 90% of screened patients will be eligible), ; • Recruitment (equal to or more than 90% of eligible patients will consent to trial participation), ; • Retention and attrition (equal to or less than 5% of participants will be lost to follow up including those who withdraw consent),; • Protocol adherence (equal to or more than 90% of randomised participants receive their randomised intervention), ; • Missing data (equal to or less than 5% data will be missing), ; • Effect size (this will inform future sample size calculations), ; • Patient satisfaction (of PVC at insertion and removal, scored 0 (dissatisfied) to 10 (completely satisfied)).; [On device removal (eg. patient satisfaction) or at the time of trial completion (eg. missing data), as appropriate.] SECONDARY OUTCOME: Cost effectiveness: estimates of costs of staff resources, equipment and PVC failure resource usage with previously developed cost estimations. ; ; Equipment resources (volume) (eg. needleless connector use) will assessed by either the Research Nurse (upon insertion and during daily checks); staff resources (eg. time to insert PVC) will be estimated and extrapolated from published literature in a similar population with PVC.[Daily from device insertion until the time of device removal. ] CRBSI (collected as per current clinical treatment); defined as per the National Health and Safety Network (BSI‐LCBI) criteria. ; ; ; ; ; ; ; ; ; Infection outcomes will be assessed from the time of device insertion to 48 hours after device removal.] PVC dislodgment (partial) or accidental removal (completely leaves vein). ; ; 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) ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record (including microbiology results). ; Collection of microbiological specimens (eg. blood, skin swabs, tips) will be as per the patient's treating team (not the Research Team).[From the time of device insertion to 48 hours after device removal.] Infiltration (the movement of IV fluids into the surrounding tissue); with or without extravasation (ie. infiltration resulting in damage to surrounding tissue). ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until the time of device removal. ] Local infection (collected as per current clinical treatment); defined as per the National Health and Safety Network (BSI‐LCBI) criteria. ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record (including microbiology results). ; Collection of microbiological specimens (eg. skin swabs, tips) will be as per the patient's treating team (not the Research Team).[From the time of device insertion to 48 hours after device removal.] Occlusion (the PVC will not flush or leaks when flushed) ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until the time of device removal. ] Phlebitis: defined as pain/tenderness alone (>2); or two or more signs/symptoms of: pain (0‐10); tenderness (0‐10); erythema, swelling, or palpable cord (any, recorded in cm); or purulent discharge (any). ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until device removal. ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until the time of device removal. ] PVC dwell time: from the time of PVC insertion until removal from either device failure, routine replacement or the completion of IV therapy. ; This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.[Daily from device insertion until the time of device removal. ] 5. Able to provide written informed consent.