Time to Oxygenation during ‘CICO’ Simulation: Rapid-O2 insufflation Device versus Manujet Ventilator

The study aim is : to investigate the time taken for medical and nursing anaesthesia staff to set up the Rapid-O2 oxygen insufflation device and compare this with the Manujet ventilator in a simulated ‘CICO’ (Can’t Intubate, Can’t Oxygenate) scenario. The two 'arms' of the intervention will be; Arm 1: measuring the time taken to set up the Rapid-O2 oxygen insufflation device in a simulated CICO scenario Arm 2: measuring the time taken to set up the Manujet ventilator in a simulated CICO scenario Study design: Following ethics approval, fully informed participant consent and ANZCTR registration, this prospective randomised controlled trial will be conducted in the Nepean Hospital theatre complex over a period of three years. Participants will include randomly selected anaesthetists, anaesthetic trainees and anaesthetic and recovery room nurses. The level of experience, previous clinical experience with a similar scenario, and, previous experience with the devices will be documented. The study will be conducted in the location where the participant spends most of their time (in theatre for anaesthetic nurses and medical staff and in the recovery room for recovery nurses). Participants Eligible participants will include all medical staff as well as anaesthetic and recovery nurses. Subjects can decline or withdraw their consent for participation at any time. Subject identification will be removed following data collection at the completion of the study. The order of oxygenation technique that the participants utilise will be randomised. Description: The study interaction will commence by declaring a 'Can't oxygenate, can't ventilate' CICO scenario to the subject whilst performing cannula cricothyroidotomy on a mannequin by an anaesthetist. As the cannula is being inserted either the Rapid-O2 or the Manujet will be handed to the participant depending on randomisation, at which point the study investigator will instruct the participant to simply “prepare the device for delivery of oxygen via the cannula”. Audible pulse oximetry with decreasing oxygen saturation will also be provided to simulate urgency at predetermined time intervals during the scenario. No further prompts will be provided. The endpoint with both the Rapid-O2 and Manujet will be defined as the time point in which a breath of oxygen is delivered. A timer will record the time interval from the time the participant is prompted to ready the device for oxygenation to delivery of a breath. It is expected that each 'session' from start to finish will be a 20 minute duration. The Manujet ventilator is the traditional oxygenator of choice in cannula-based CICO rescue techniques but has many design features which limit its utility in in a time-pressured crisis such as the need for a mains oxygen supply, multiple-step setup, and potential for significant harm with misuse. Nevertheless, the Manujet remains the oxygenator of choice at many institutions and among many anaesthetists (ref for this statement). We aim to investigate the time taken in seconds to correctly prepare these devices (Rapid O2 insufflator or Manujet) for front of neck infraglottic oxygen rescue by naive operators (doctors and nurses with remote or minimal experience with the devices). The fidelity to the device will be monitored by making sure the device is handed to the patient after opening from the standardised packaging. We will have a checklist of instructions to make sure the device is handed to the participant in a standardised identical method.