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Trial registered on ANZCTR


Registration number
ACTRN12619000294156
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
26/02/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
26/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Time to Oxygenation during ‘CICO’ Simulation: Rapid-O2 insufflation Device versus Manujet Ventilator
Scientific title
Time to Oxygenation during ‘CICO’ Simulation: Rapid-O2 insufflation Device versus Manujet Ventilator for medical and nursing anaesthesia staff
Secondary ID [1] 297482 0
Nil known
Universal Trial Number (UTN)
U1111-1229-0406
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
airway management
311705 0
Condition category
Condition code
Anaesthesiology 310304 310304 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313733 0
Treatment: Devices
Comparator / control treatment
The interventional device is the Rapid O2 insufflation device. The control/comparator is the Manujet ventilator .

It is imperative in a 'Can't oxygenate, Can't ventilate' scenario, that the oxygen device used
can be set up with minimal delay by personnel who may have remote, or no familiarity, with its use. The Rapid-O2 oxygen insufflation device TM (Meditech Systems Ltd, Shaftesbury, UK) has many design features which make it the ideal rescue oxygenator such as ease and intuitiveness of use, quick set up, delivery of a known and accurate flow.

Control group
Active

Outcomes
Primary outcome [1] 319191 0
The primary outcome is the time taken for medical and nursing anaesthesia staff to set up the Rapid-O2 oxygen insufflation device compared to the Manujet ventilator in a simulated ‘CICO’ (Can’t Intubate, Can’t Oxygenate) scenario as assessed by a timer.
Timepoint [1] 319191 0
The primary timepoint is assessment during simulation
Secondary outcome [1] 367244 0
Our secondary outcomes: To assess the subjective ease of preparing devices on a Likert scale, with the parameters: easy, neutral or difficult.

Timepoint [1] 367244 0
The secondary timepoint is assessed during simulation

Eligibility
Key inclusion criteria
Participants will include randomly selected anaesthetists, anaesthetic trainees and anaesthetic and recovery room nurses with the following criteria;

- must work in an anaesthesia related environment (ie operating theatre, recovery room)
-between 18-80 years of age
- no intellectual disability
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- having an intellectual disability
- not working in an anaesthesia- related environment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be assured by using consecutively numbered opaque sealed envelopes containing the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a computer generated random number sequence in variable blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The Student t test and the analysis of variance (ANO-VA) will be used for testing differences between means. A P value of less than 0.05 will be considered statistically significant. Data will be presented as means -/+ SD. Using a paired t-test and a sample of N=40 paired observations would provide 95% power at the 5% level of significance to detect a mean difference of 20 seconds given a standard deviation for a difference of 20 seconds.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13220 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 25777 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 302049 0
Hospital
Name [1] 302049 0
Nepean Hospital
Address [1] 302049 0
Derby Street
Kingswood NSW 2747
Australia
Country [1] 302049 0
Australia
Primary sponsor type
Individual
Name
Tim Suharto
Address
Department of Anaesthesia
Nepean Hospital
Derby Street
Kingswood 2747 NSW
Australia
Country
Australia
Secondary sponsor category [1] 301862 0
None
Name [1] 301862 0
Address [1] 301862 0
Country [1] 301862 0
Other collaborator category [1] 280561 0
Individual
Name [1] 280561 0
Sivan Wexler
Address [1] 280561 0
Department of Anaesthesia
Nepean Hospital
Derby Street
Kingswood 2747 NSW
Australia
Country [1] 280561 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302731 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 302731 0
NBMLHD Human Research Ethics Office
Level 5 South Block
Nepean Hospital
Kingswood NSW 2747
Ethics committee country [1] 302731 0
Australia
Date submitted for ethics approval [1] 302731 0
01/04/2019
Approval date [1] 302731 0
03/05/2019
Ethics approval number [1] 302731 0
2019/ETH09885

Summary
Brief summary
We aim 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.

A Can’t Intubate/Can’t Oxygenate (CICO) scenario arises when attempts at oxygenation of the patient via the anatomical conduits of the upper airway have failed. In such a scenario, the creation of a patent airway via the front-of-neck either by cricothyroidotomy or tracheotomy remains the only option for rescue oxygenation. A variety of rescue techniques are advocated currently, including cannula-, or scalpel-based techniques as well as wire-guided techniques . Regardless of technique chosen the CICO scenario in anaesthetic practice is often poorly managed with potentially catastrophic outcomes. Important contributory factors include institutional ill-preparedness and equipment not fit-for-purpose. Delays in providing rescue oxygenation, even when appropriate equipment is available, is an additional factor implicated in poor outcome.

Our hypothesis is that the Rapid-O2’s simplicity and intuitiveness allow for its setup by naive operators in a clinically acceptable timeframe versus the manujet during a simulated CICO scenario.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91194 0
Dr Tim Suharto
Address 91194 0
Nepean Hospital Department of Anaesthesia
Derby Street
Kingswood NSW 2747
Australia
Country 91194 0
Australia
Phone 91194 0
+61 2 4734 2000
Fax 91194 0
Email 91194 0
timsuharto@gmail.com
Contact person for public queries
Name 91195 0
Dr Sivan Wexler
Address 91195 0
Nepean Hospital Department of Anaesthesia
Derby Street
Kingswood NSW 2747
Australia
Country 91195 0
Australia
Phone 91195 0
+61 2 4734 2000
Fax 91195 0
Email 91195 0
sivanwexler@gmail.com
Contact person for scientific queries
Name 91196 0
A/Prof Allan Cyna
Address 91196 0
Nepean Hospital Department of Anaesthesia
Derby Street
Kingswood NSW 2747
Australia
Country 91196 0
Australia
Phone 91196 0
+61 2 4734 2000
Fax 91196 0
Email 91196 0
allan.cyna@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality reasons , individual participant data will remain anonymous.
What supporting documents are/will be available?
No other documents available
Summary results
No Results