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A bundle for anaethetists to reduce postoperative infection: the Anaesthetists Be Cleaner (ABC) study

The effect of implementing a bundle for anaesthetists to reduce postoperative infections: a stepped wedge cluster randomised multi-site trial. The Anaesthetists Be Cleaner (ABC) Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000407291
Acronym
ABC
Enrollment
9000
Registered
2018-03-21
Start date
2018-11-19
Completion date
2021-08-13
Last updated
2022-02-07

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

Conditions

None listed

Brief summary

The problem Postoperative infection. Rationale We know that anaesthetists inadvertently inject potentially pathogenic micro-organisms into about 6% of patients. We do not know whether this matters clinically, but it is a plausible cause of post-operative infections in operations such as major hip and knee arthroplasty and cardiac surgery. Objectives To demonstrate the clinical importance of inadvertent intravenous (IV) injection of micro-organisms during anaesthesia using two endpoints: 1. Days alive and out of hospital (DAOH) at 90 days post-surgery. 2. Rates of surgical site infection (SSI) from the National Surgical Site Infection Improvement programme reports. Endpoints Our primary end-point is the patient-centred measure, days alive and out of hospital in the 90 days following surgery. As a secondary endpoint we will also measure the rate of SSI in patients undergoing hip or knee arthroplasty and cardiothoracic surgery. These infections include a) superficial incisional SSI; b) deep incisional SSI; (c) organ/space SSI; (d) pneumonia; and (e) septicaemia, all occurring within 30 days (superficial incisional) or 90 days of surgery, while in hospital, after surgery, or requiring re-admission to hospital. These are important explanatory measures, but will not capture all forms of infection. By contrast, quantifying the difference between groups in days alive and out of hospital will provide a compelling quantification, the practical clinical importance of all manifestations of infection, and of the potential benefit of our proposed intervention. Design We will use a service-based, “real world”, prospective, modified stepped-wedge, quality improvement design to evaluate a bundle of measures for improving key anaesthetic practices related to the aseptic drawing up and administering of IV medications, to hand hygiene, and to maintaining a clean work space to prevent injection of micro-organisms, by anaesthetists, on postoperative infection, and hence the clinically relevant and patient-centred measure, days alive and out of hospital, in the 90 days following surgery.

Interventions

The intervention will involve the implementation of the bundle outlined below. 1. Wipe skin with 70% alcohol (with or without 2% chlorhexidine) and allow to dry before inserting any IV line. 2. Inject all IV bolus medications except propofol through a 0.2micron filter incorporated into each patient’s IV line. • Use aseptic technique when attaching the filter to the IV and, unless it has been freshly opened from sterile packaging, wipe the IV injection port with 70% alcohol (with or without 2% c

The intervention will involve the implementation of the bundle outlined below. 1. Wipe skin with 70% alcohol (with or without 2% chlorhexidine) and allow to dry before inserting any IV line. 2. Inject all IV bolus medications except propofol through a 0.2micron filter incorporated into each patient’s IV line. • Use aseptic technique when attaching the filter to the IV and, unless it has been freshly opened from sterile packaging, wipe the IV injection port with 70% alcohol (with or without 2% chlorhexidine) for 15 seconds and allow to dry. • If the filter is moved from one access point to another during the case the new access point should first be wiped with 70% alcohol (with or without 2% chlorhexidine) for 15 seconds and allowed to dry. • Use more than one filter if necessary or desired (e.g. for cardiac patients, one filter in the peripheral line, one on a central line port where bolus medications may be given, and a third onto the medication injection port on the bypass machine for the perfusionist to use when administering medications). • Remove the filter(s) on discharge from the Post Anaesthesia Care Unit or on admission to the Intensive Care Unit. 3. Use meticulous aseptic technique when drawing up or injecting propofol, and discard syringes, needles or the medication in the event of any suspected contamination: • Note that the rubber bungs on propofol vials are not sterile even with the cap in place, so they should be wiped with alcohol (with or without chlorhexidine) for 15 seconds and allowed to dry before propofol is drawn up. If the medication is supplied in an ampoule, wipe the outside of the neck and surrounding part of the ampoule with alcohol (with or without chlorhexidine) before opening. • Use a new needle or spike for each occasion. • Cap the syringe with a syringe cap or capped needle. • Administer as soon as possible and discard propofol after one hour if not used. • Do not reuse syringes or needles for propofol, even for the same patient. • Flush IV port with sterile sodium chloride 0.9% or sterile water for injection after propofol has been administered to ensure no residual propofol remains to support bacterial growth. 4. Perform hand hygiene: • Before and after interacting with each new patient (i.e. on entering the operating room and on leaving a patient in the Post Anaesthesia Care Unit). • Before and after any procedure creating risk of infection (e.g. IV insertion, airway manipulation, administering propofol, etc). • After blood and body fluid exposure (e.g intubation, IV line insertion etc); remove gloves (if they have been worn) and, if practicable, perform hand hygiene before spreading contamination to the work station, computer key board and other surfaces. 5. Maintain clean working surfaces: • Place used laryngoscopes, masks and other contaminated objects into a tray designated for this exclusive purpose; maintain strict separation of clean and contaminated areas - do not use this tray for clean instruments, swabs or other items even at the start of a procedure. • Wipe the anaesthetic machine bench top and the circuit pressure-relief valve with alcohol (with or without chlorhexidine) once the patient has settled into the maintenance phase of anaesthetic (i.e. after intubation of the trachea if this is done). NOTES: • Propofol should not be injected through the filter. • The filter has a dead space of 0.45 mL and the injection port has a dead space of 0.11 mL (= 0.56 mL in total); therefore, as with any IV setup, it is necessary to prime the filter with sterile sodium chloride 0.9% or sterile water for injection to eliminate air, and it is also necessary to ensure that medications are flushed through. • Hand hygiene implies either hand washing with medicated soap and water or using alcohol-based hand rub; it is important for hands to dry properly. • Provided the medications are injected through a 0.2micron filter, the study does not ask for hand hygiene in relation to the injection and drawing up of medications other than propofol. The bundle will be presented to each study site by the investigators and site champions (we already have anaesthetists who have volunteered to be site champions for the study) and additional information in the form of emails to each department, study information sheets, videos and a study website will also be used. Evaluation of current aseptic practices and changes to these after implemetnation of the bundle will be observed by indepentent medically trained personnel e.g. medical students. Aseptic processes defined in the bundle will be measured using a simple behaviourally anchored scale developed for the study.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

All patients undergoing hip or knee arthroplasty or cardiothoracic surgery (as defined by the Surgical Safety Infection Improvement programme) in the study hospitals during the active phase of the study under general anaesthesia with or without regional anaesthesia, or under regional anaesthesia with sedation.

Exclusion criteria

Heart and lung transplants will be excluded from the study because of their complexity and the use of immunosuppression in these cases.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026