Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000001190
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
8/01/2019
Date last updated
5/02/2020
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of CICO Kit Ergonomic Design on the Timed Responses of Participants in Simulated Can’t Intubate Can’t Oxygenate Crisis: A Randomised, Cross-over Pilot Study
Scientific title
The Impact of CICO Kit Ergonomic Design on the Timed Responses of Participants in Simulated Can’t Intubate Can’t Oxygenate Crisis: A Randomised, Cross-over Pilot Study
Secondary ID [1] 296928 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway Emergency 310877 0
Condition category
Condition code
Anaesthesiology 309553 309553 0 0
Anaesthetics
Respiratory 309560 309560 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Can't Intubate, Can't Oxygenate' (CICO) crisis is a serious airway emergency that anaesthetists are trained to rapidly recognise and manage. In a CICO situation, the anaesthetist and their assistant seeks to secure an airway through a front of neck access technique, which is known as an infraglottic rescue. This is required when upper airway techniques have been unsuccessful (e.g. best optimised attempts at bag-mask ventilation, laryngeal mask airway, endotracheal or breathing tube airway). Infraglottic rescue involves the use of CICO equipment and rescue techniques with the aim of establishing oxygenation and / or ventilation. Whilst every hospital institution has a variety of equipment available to help anaesthetists achieve an infraglottic rescue airway, equipment may be stored on different trolleys or packaged and presented in different ways. The location of such equipment may also be distant, in different drawers or limited to certain areas in a clinical workspace. From an ergonomic perspective, packaging equipment into a uniform kit may enable faster accessibility of essential equipment to provide the practitioner with the best chance for responding rapidly to this evolving airway emergency. It is postulated that the strategic storage, organisation and uniformity of pre-packaged essential CICO equipment within a CICO folder kit will serve to enhance accessibility and also act as a visual-cognitive aid in a crisis, which may reduce the cognitive burden, attenuate the stress response and enhance performance of practitioners and their assistants.

This project primarily aims to compare the physiologic and timed responses of participants in a simulated CICO crisis using institutional specific equipment versus a pre-packaged CICO equipment kit. Timing responses would involve the following:
- Time to recognition of CICO situation
- Time to obtaining infraglottic rescue equipment from request
- Time to performing successful CICO rescue including infraglottic rescue technique, oxygenation and ventilation.
- Time to conversion between CICO rescue techniques

Physiologic responses will comprise of:
- Heart rate electronic monitoring.
- Physiological responses detailed in pre-and-post crisis questionnaires and may be related to:
i. General health such as diet, sleep and level of arousal.
ii. Current level of stress.
iii. Specific times of stress during the simulation.
iv. Perceptions of the level of stress of other participants during the simulation.

Participants will be recruited from the department of Anaesthesia, Pain and Perioperative Medicine at Fiona Stanley Hospital:
i. This may include consultant anaesthetists, registrars and technicians.
ii. Inclusion criteria will be a staff member who is fit and able to perform their ordinary professional duties that is expected and within their scope of current practice.
iii. Exclusion criteria will be a staff member who expresses a desire to not participate in this study or who is otherwise unfit or unable to safely carry out their expected and ordinary professional duties at work.

A participant may withdraw at any stage of the study. Data up to the point of withdrawal will remain as part of the study to ensure internal validity. This has been outlined in the consent information sheet and consent to participate agreement.

After simple randomisation of participants to either institutional CICO equipment or a pre-packaged CICO kit, this is to be then followed immediately by the alternate equipment arm. This is an intentional crossover of equipment arms to reduce bias associated with the study. The location of the simulations will occur in the usual work environment of participants such as the surgical theatre area with access to an anaesthetic ventilator, airway trolley, difficult airway trolley, other airway equipment (e.g. video laryngoscopy, fiberoptic scopes) and visual cognitive aids (e.g. Vortex Approach) as would be normally available at Fiona Stanley Hospital.

Scenarios used will be standardised (see Appendix 1 below). A simulation pre-brief and debrief session will be conducted by simulation anaesthesia fellows to ensure that participant physical and psychological safety as well as confidentiality is maintained. In order to ensure a certain level of realism as does occur in real-life practice, it will be at the discretion of the simulation anaesthesia fellows to adapt the scenarios in response to the actions of participants to ensure a high fidelity is achieved. Simulation anaesthesia fellows will not be blinded to scenarios performed. A simple stop-clock device and manual recording of times will be used to record observations. Overall, the simulation anaesthesia fellows will be supervised by a consultant anaesthetist with simulation fellowship experience.

Appendix 1:
- Scenario:
For participants using CICO equipment at their institution or pre-packaged CICO kit:
- A 35-year-old male is planned for an emergency laparotomy on the background of acute perforated small bowel obstruction. The patient is morbidly obese but without any past medical history, medication history or allergy. Documented airway assessment consisted of Mallampatti grade 4, shortened thyromental distance <6cm, reduced mouth opening and limited neck extension. Please plan and prepare for a general anaesthetic.

1) Trigger 1: Failure of best optimised upper airway techniques (e.g. bag mask ventilation, laryngeal mask insertion, endotracheal tube insertion). Progress to CICO rescue on neck mannequin.
2) Trigger 2: If needle cricothyroidotomy is used, trigger is for simulation fellows to explain procedure needs to proceed. Decision to convert to Melker may then be made by participants.
3) Trigger 3: If either needle or scalpel-bougie technique is used, then time for response of pulse oximetry saturations to rise should occur within 30 seconds.
4) Trigger 4: At the discretion of simulation anaesthesia fellows, if there remains no decision by participants to proceed with an airway that provides effective ventilation in addition to oxygenation, the participants may be prompted to do so.
5) Settings on mannequin: Pre-induction SIM-man 3G settings included a blood pressure of 130/80 mmHg, sinus rhythm heart rate of 130 beats per minute and oxygen saturations of 98%. On successive failed attempts at supraglottic airway management, oxygen saturations were gradually decreased from 98% down to 82% with a concomitant rising tachycardia. The crisis evolved over a period of 90 seconds from the start of simulation. Successful cricothyroidotomy resulted in an initial rise of oxygen saturations by 5%. Oxygen saturations were intentionally kept at a minimum of 82% to avoid inadvertently distracting participants into preparing for a cardiac arrest scenario.
Intervention code [1] 313200 0
Treatment: Devices
Comparator / control treatment
Comparator:
- Compact, uniform CICO folder kit containing all essential cricothyroidotomy equipment including cannula (x3 14G Insyte IV cannulas, 5ml syringe (non-luer lock), 10ml ampoule of normal saline, rapid O2 insufflation device.), scalpel-bougie (scalpel (size 10 blade), bougie, rapi-fit adapter (15mm connector), 6.0 cuffed endotracheal tube) and Melker Seldinger technique equipment. The comparator kit is based on the CICO kit by Dr. Foong WM, et al (see below) with a few modifications such as the use of extra 14G Insyte cannulas, Velcro side strap along the spine of the kit and use of local-institutional algorithms.

Reference: Foong W.M, Wyssusek K.H, Culwick M.D, Van Zundert A.A.J. Rising to the occasion - institutional standardization and organization of equipment for 'can't intubate, can't oxygenate' (cico) crisis. Acta anaesthesiologica belgica. 2017;68(3):103-110.

Control: Your institutional CICO equipment.

At Fiona Stanley hospital (FSH Kit) this consists of:
- x1 sachet containing: initial cricothyroidotomy equipment (6.0 ETT, x2 5ml syringe, x2 14G Insyte Cannula, x2 20ml saline, scalpel size 10 blade, x1 rapi fit adapter).
- Bougie: supplied from airway trolley
- Melker Universal Kit (Surgical and Seldinger) equipment: supplied from difficult airway trolley
Control group
Active

Outcomes
Primary outcome [1] 318504 0
Timed responses of participants in a simulated CICO crisis using standardised institutional equipment versus a CICO kit. A simple stop-watch will be utilised to record observations.
Timepoint [1] 318504 0
Timed event to achieving successful:
- Infraglottic rescue technique
- Oxygenation
- Ventilation
based on commencement of simulation or from CICO recognition.

- Time equipment received from it being requested
Primary outcome [2] 318515 0
Physiological responses of participants in a simulated CICO crisis using standardised institutional equipment versus a CICO kit
Timepoint [2] 318515 0
Electronic heart rate monitoring will (commence at the start of and) cease by the end of the simulation.
Secondary outcome [1] 365179 0
Physiological responses of participants in a simulated CICO crisis using standardised institutional equipment versus a CICO kit
Timepoint [1] 365179 0
A specifically developed questionnaire for this simulation will be used pre-and-post simulation.

Eligibility
Key inclusion criteria
Anaesthetic staff providers including:
- Consultant anaesthetists
- Trainee or registrar level anaesthetic staff
- Anaesthetic technicians or registered nurses
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are excluded may fall under one or more categories described below:
- Do not wish or consent to participate.
- Wish to withdrawal after consent (data up to the point of withdrawal will however be included as part of statistical analysis)
- Unable to perform their usual occupational duties (e.g. due to illness, other reasons)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed. Not practically feasible to conceal allocation.

Participants will be randomised to using either institutional equipment or the kit at the first instance, followed by a cross-over with the use of the other kit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (coin tossing)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis would involve:
1) Student t-tests
2) Order of effects analysis
3) Learning model analysis to adjust for the order of effect
4) Non-parametric/parametric statistical analyses depending on data generated

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2019
Actual
10/01/2019
Date of last participant enrolment
Anticipated
5/05/2019
Actual
29/01/2019
Date of last data collection
Anticipated
5/05/2019
Actual
29/01/2019
Sample size
Target
30
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12787 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 25248 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 301501 0
Hospital
Name [1] 301501 0
Fiona Stanley Hospital, South Metropolitan Area Health Service
Country [1] 301501 0
Australia
Primary sponsor type
Individual
Name
Dr. Justin Ti
Address
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country
Australia
Secondary sponsor category [1] 301196 0
Individual
Name [1] 301196 0
Dr. Sean Dwyer
Address [1] 301196 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country [1] 301196 0
Australia
Secondary sponsor category [2] 301202 0
Individual
Name [2] 301202 0
Dr. Claire McTernan
Address [2] 301202 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country [2] 301202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302244 0
South Metropolitan Health Service Human Research Ethics Committee (EC00265)
Ethics committee address [1] 302244 0
Ethics committee country [1] 302244 0
Australia
Date submitted for ethics approval [1] 302244 0
03/10/2018
Approval date [1] 302244 0
31/10/2018
Ethics approval number [1] 302244 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89562 0
Dr Justin Ti
Address 89562 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country 89562 0
Australia
Phone 89562 0
+61 8 6152 2222
Fax 89562 0
Email 89562 0
[email protected]
Contact person for public queries
Name 89563 0
Sean Dwyer
Address 89563 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country 89563 0
Australia
Phone 89563 0
+61 8 6152 2222
Fax 89563 0
Email 89563 0
[email protected]
Contact person for scientific queries
Name 89564 0
Justin Ti
Address 89564 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch
Perth, Western Australia
6150
Country 89564 0
Australia
Phone 89564 0
+61 8 6152 2222
Fax 89564 0
Email 89564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.