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Trial registered on ANZCTR


Registration number
ACTRN12620000579998
Ethics application status
Approved
Date submitted
12/05/2020
Date registered
19/05/2020
Date last updated
10/06/2021
Date data sharing statement initially provided
19/05/2020
Date results provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
In a simulation environment, is there a difference in time taken for consultant anaesthetists to perform spinal anaesthesia as compared to general anaesthesia on women, with suspected or confirmed COVID-19, who require emergency caesarean delivery?
Scientific title
The time to perform spinal or general anaesthesia in COVID-19 positive parturients requiring emergency caesarean delivery: A prospective crossover simulation study
Secondary ID [1] 301268 0
Nil known
Universal Trial Number (UTN)
U1111-1251-9551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronavirus (COVID-19) 317440 0
Performance of anaesthesia in simulation for patients with Coronavirus 317441 0
Condition category
Condition code
Infection 315532 315532 0 0
Other infectious diseases
Anaesthesiology 315569 315569 0 0
Anaesthetics
Reproductive Health and Childbirth 315597 315597 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions group:
Simulation General Anaesthesia: GENERAL ANAESTHESIA (GA) for emergency caesarean delivery category 1 (Cat -1) in a patient with confirmed COVID – 19.
Simulation Spinal A: SPINAL ANAESTHESIA (SA) for emergency caesarean delivery category 1 (Cat -1) in a patient with confirmed COVID – 19.

The second intervention will occur immediately after the first intervention once the simulation setting is ready to start.


Simulators

1. General Anaesthesia - SiMoM (Laerdal Medical, Stavanger, Norway). The intubation will be a Cormack & Lehane grade-1 laryngoscopic view, allowing intubation on the first attempt. There will be an intravenous line connected to fluids in the simulator where medications can be injected.

2. Spinal Anaesthesia - Spinal injection simulator (Lifeform® Spinal Injection Simulator / NASCO, Fort Atkinson). For this simulation, an actor will simulate a pregnant patient to be seated in position for the procedure. There will be a line connected to fluids to simulate an intravenous line. Once the actor is in adequate position, the spinal simulator will be put on his side. The SA will be performed in the simulator.


For both interventions

To maintain a realistic simulation, the flowchart used by the participant and the actors for the simulation is the same used in our institution for management of suspected or confirmed COVID – 19 patients. Consultants will have to follow the Mackay Hospital and Health Service “Perioperative Workflow for Suspected or Confirmed COVID-19 Cases”. This flowchart based on recommendations on the Perioperative management of suspected/ confirmed cases of COVID-19 (1). Not all the roles involved in a real case of a CD for COVID-19 will be performed due to the difficulties of gathering the number of people necessary for that. However, all the roles that were considered essential to maintain a realist simulation will be performed by real staff or actors. They are:
- Participant: Anaesthetic consultant
- Non real pregnant person
- Anaesthetic team (always real staff): Anaesthetic trainee, anaesthetic nurse
- Obstetric team: Staff specialist
- Nurse staff x 1
- Theatre assistant to transfer and position the patient
- Nurse staff outside theatre on the phone for communication and to provide extra equipment of needed by the participant

Facilitator: Research team

Other considerations based on the on the Perioperative management of suspected/ confirmed cases of COVID-19 are:


Preoperative considerations:
1. The preoperative preparation, including use of Personnel Protective Equipment (PPE) and using the dedicated operating theatre for COVID -19 patients.
PPE: Scenarios involving Aerosol Generating Procedures (AGPs) such as GA. It is safe and appropriate to use airborne precautions. Scenarios not involving AGPs such as NA. It is safe and appropriate to use droplet precautions. Droplet and airborne protections are based on the “Australian and New Zealand College of Anaesthetists (ANZCA) statement on personal protection equipment during the SARS-CoV-2 pandemic”.2
2. The number of Staff required and their roles (in details on the scenario overview below)
3. The equipment necessary (In details below)
4. The transference of to the Operating Table
5. For the GA scenario only: The protection of other staff and the patient is done by using a Frame / Clean Plastic C-Armor Drape on top of the patient and performing induction of anaesthesia following a systematic approach to minimise AGPs:
a. Anaesthetic registrar reads the flowchart for intubation. This approach minimises AGPs and contamination. The consultant will only deal with the facemask seal, ventilation and intubation of the airway. The anaesthetic registrar will inject all medication requested by the consultant and will help with the bag ventilation. The anaesthetic registrar will be in charge of the oxygen flow during induction. He / she should decrease the oxygen flow when the facemask is not in contact with the patient to minimize AGP. Only the anaesthetic registrar will change the anaesthetic machine settings. The anaesthetic nurse will provide all the equipment necessary for ventilation and intubation of the patient as per request of the consultant (equipment in details below).
6. For NA scenario: Once patients arrive in theatre, they are put in a sitting up position for performance of spinal anaesthesia. There is no specific flowchart for this situation since performing spinal anaesthesia already requires the use of droplet precautions and it is a non AGP procedure. Therefore, the consultant will be expected to be prepared for perform the procedure once the patient has assumed a sitting up position. The medication he / she will use will be decided by his / her discretion. The manner how the consultant will test the block is also by his / her discretion. Formal testing of the block prior to commencement of surgery is mandatory in this scenario. The level of the block must be checked bilaterally. There is no consensus as to the best practice about checking the block. However, three modalities like, sensation of cold (ice cubes or ethyl chloride spray), light touch (cotton swab), and loss of motor power are used commonly.3 Although level of block needed for abolishing somatic pain during caesarean delivery is T10 dermatome, a block as high as T4 is required to abolish visceral pain and discomfort. The decision to when to start will be by the discretion of the staff anaesthetist. Usually, 5 – 8 minutes is adequate to achieve a block height to T4 depending on the medications used. For study purposes, we will accept 3 and 6 minutes as an acceptable time after intrathecal injection to achieve T10 and T4 level respectively.

Intraoperative considerations are not required for the scenario since the simulation stops at the time of the surgical start.

Simulation patient details:
- Name: Sharon
- Age: 25
- G1P0
- Confirmed COVID 19 with mild respiratory symptoms and no fever
- Spontaneous labour
- 6 cm dilated she has a prolonged foetal bradycardia requiring an emergency Caesarean delivery
- Past medical history: Nil
- Medications: Nil
- Allergies: No known allergies
- Non-smoker, no use of alcohol in pregnancy
- Weight: 70 kg
- Height: 1.70 metres
-2x intravenous set with fluids will be attached to arms (one in each side) to simulate the intravenous set to provide medications



Equipment Required:
- Spinal simulator
- Cardiotocography
- Medications: Propofol, thiopentone, ketamine, suxamethonium, fentanyl, alfentanil, thiopentone, metaraminol, ephedrine, rocuronium, atropine, antibiotics, carbetocin (These will be fake medications to avoid waste)
- Plastic sheet and frame to cover patient for intubation
- Programmable monitors showing: Saturation of 97%, heart rate of 110 bpm, blood pressure of 130x90 mmHg.
- Anaesthetic machine, designed COVID -19 anaesthetic trolley with pre-prepared medications
- Airway equipment including a number of endotracheal tubes, laryngeal masks, oral pharyngeal airways, bougie, stylet, video – laryngoscope and normal intubation equipment
- 2 infusion pumps.
- PPE: Gown or apron / P2/N95 / protective eyewear / Sterile gloves if required / Non-sterile gloves / Theatre cap / Shoe covers
- Spinal kit: standard epidural pack (gown, sterile field, syringes, drape, gauze, towel), spinal needle 25G, lidocaine 1% 5mL, heavy bupivacaine 0.5%, chlorhexidine 2% swab stick.
- Documentation: At Mackay Base Hospital, all the documentation is done in a computer program. The usual anaesthetic documentation will be required. The computer can be used without assigning any patient.

Simulation GA: GENERAL ANAESTHESIA for emergency caesarean delivery in a patient with confirmed COVID – 19.

SCENARIO OVERVIEW (GA ONLY)
The consultant will be called for an emergency category 1 caesarean delivery by the facilitator. The facilitator will inform the consultant about the current situation and patient details.

SETUP PART 1 - PHONE CALL
The participant will receive a phone call where he or she will be informed about an emergency CAT – 1 CD.
Facilitator script:
- Hi Dr. … It is John, your anaesthetic trainee for the day. The obstetric team (O&G) has just informed me about a 25-year-old patient with persistent foetal bradycardia of 60 beats per minute (bpm) for 10 minutes requiring an emergency CD. I am with her now and they are preparing her to take to the operating theatre (OT). She is a gravida 1 para 0 (G1P0) patient with confirmed COVID – 19. She has mild respiratory symptoms and no other medical conditions. She has no fever. Her investigations are normal, and the airway examination looks normal. She tells me she refuses spinal anaesthesia and she wants to be asleep during the procedure. I am going to theatre now to meet you in there and help with the preparation. Please let the obstetric team know when you are ready to bring the patient. I will call the OT coordinator and activate the team.

PART 2 – OT PREPARATION
Preparations for GA (Equipment outside OT)
All staff in this scenario should wear PPE for airborne precautions
1. Participant functions
- Prepare for GA like he would normally do for an emergency CAT 1 caesarean delivery for a COVID – 19
- Uses the local guidelines to prepare the OT to receive a patient with COVID – 19 including airway choice
- Call for the patient when everyone is ready
- Meet the patient in the dedicated COVID – 19 OT
2. Anaesthetic nurse
- Prepare all the airway equipment following the COVID-19 stored equipment checklist
3. Anaesthetic trainee functions
- Helps to set up OT for GA
- Confirm medications, circuit and equipment
- Confirms equipment and checklists
4. Obstetric consultant
- Arrives with the patient
- Stays with patient for transfer and delivery
5. Remaining Nursing staff
- Prepare for the emergency CD surgical kits (fake kits to avoid waste)
- Setup the anteroom phone speaker
- Performs preoperatory checklists
- Confirms theatre ready to receive patient and Obstetrics team will transport straight into theatre
- Confirm QLD Health “Sign In”: Check patient details, surgery and consent


PART 3 – OT entrance
1. Patient is brought to theatre directly wearing a surgical mask and using a cardiotocography machine (CTG). The O&G team is accompanying the patient. The participant, the anaesthetic trainee, the obstetric trainee and a nurse staff will meet in the theatre.
2. Participant will perform a preoperative assessment if he / she wants at this moment. The facilitator will answer possible questions
3. The obstetric consultant will inform the foetal heart rate is still 60 bpm
4. Transfer of patient to theatre bed occurs
5. Anaesthetic nurse connects the electrocardiogram (ECG) dots, monitoring wires and blood pressure cuff to the patient (Programmable monitors showing: Saturation of 97%, heart rate of 110 bpm, blood pressure of 130x90 mmHg)
6. In the meantime O&G Team (once patient is inside) request exit via the phone speaker, doffs then sterile scrubs



INDUCTION OF ANAESTHESIA

Before or after induction depending on the participant decision: scrub nurse disinfects abdomen +/- sterile drapes

1. Anaesthetic trainee – reads checklists and reviews drugs and procedure. Intubation protocol occurs
2. The mode of delivery and the medications to be given for anaesthesia will be determined by the discretion of the consultant anaesthetist
3. Once the medications are injected, we will consider that intubation occurs 1 minutes after the last drug given
4. Procedure: When the participant informs the obstetric team that the patient is ready for the procedure the scenario ends


SCENARIO OVERVIEW (SPINAL)
Simulation NA: NEURAXIAL ANAESTHESIA for emergency caesarean delivery in a patient with confirmed COVID – 19.
The consultant will be called for an emergency category 1 caesarean delivery by the facilitator. He will inform the consultant about the current situation and patient details.

SETUP
PART 1 - PHONE CALL
The participant will receive a phone call where he or she will be informed about an emergency CAT – 1 CD.
Facilitator script:
- Hi Dr. … It is John, your anaesthetic trainee for the day. The obstetric team has just informed about a 25-year-old patient with persistent foetal bradycardia of 60 beats per minute (bpm) for 10 minutes requiring an emergency CD. I am with her now and they are preparing her to take to the OT. She is a G1P0 patient with confirmed COVID – 19. She has mild respiratory symptoms and no other medical conditions. She has no fever. Her investigations are normal, and the airway examination looks normal. She tells me she refuses general anaesthesia and she wants to be awake during the procedure. I am going to theatre now to meet you in there and help with the preparation. Please let the obstetric team know when you are ready to bring the patient.
PART 2 – OT PREPARATION
Preparations for NA (Equipment outside Theatre)
All staff in this scenario should wear PPE for airborne precautions
7. Participant functions
- Prepare for NA like he would normally do for an emergency CAT 1 caesarean delivery for a COVID – 19
- The choice of medications to be given for the procedure will be determined by the discretion of the consultant anaesthetist. The mode of administration will be the intrathecal space
- Uses the local guidelines to prepare the OT to receive a patient with COVID – 19 including airway choice
- Call for the patient when everyone is ready
- Meet the patient in the dedicated COVID – 19 OT
8. Anaesthetic nurse
- Prepare all the airway equipment following the COVID-19 stored equipment checklist
9. Anaesthetic trainee functions
- Helps to set up OT for Spinal
- Confirm medications, circuit and equipment
- Confirms equipment and checklists
10. Obstetric consultant
- Arrives with the patients
- Stays with patient for transfer and delivery
11. Nursing staff
- Prepare for the emergency CD surgical kits
- Setup the anteroom phone speaker
- Performs preoperatory checklists
- Confirms theatre ready to receive patient and Obstetrics team will transport straight into theatre
- Confirm QLD Health “Sign In”: Check patient details, surgery and consent



PART 3 – OT entrance
9. Patient (actor) is brought to theatre directly wearing a surgical mask and using a CTG. The O&G team is accompanying the patient. The participant, the anaesthetic trainee, the obstetric trainee and a nurse staff will meet in the theatre.
10. Participant will perform a preoperative assessment if he / she wants at this moment. The facilitator will answer possible questions
11. The obstetric consultant will inform the foetal heart rate is still 60 bpm
12. Transfer of patient to theatre bed occurs
13. Anaesthetic nurse connects ECG dots, monitoring wires and blood pressure cuff to the patient (Programmable monitors showing: Saturation of 97%, heart rate of 110 bpm, blood pressure of 130x90 mmHg)
14. In the meantime O&G Team (once patient is inside) request exit via the phone speaker, doffs then sterile scrubs

SPINAL ANAESTHESIA
Anaesthetic trainee – checklists and reviews drugs and procedure. Spinal protocol occurs

1. Preparation of the patient like he would normally do for spinal anaesthesia
2. When ready for the procedure, the facilitator will request the SA to be performed in the SA simulator. The facilitator will inform the participant that the level of blockade can be asked to the facilitator
3. Once the injection of anaesthetic occurs, the facilitator will remove the simulator and request the consultant to continue as usual
4. Scrub nurse disinfects abdomen +/- sterile drapes when the participant allows
5. After 3 minutes the facilitator, if asked, will inform that the level of block is at T10
6. After 6 minutes the facilitator, if asked, will inform that the level of block is at T4
7. Procedure: When the participant informs the obstetric team that the patient is ready for the procedure the scenario ends
END OF SCENARIOS:
Consultants will be asked how stressful they believe it was the simulation scenario in a scale of 0 to 10. Zero being no stress at all and 10 being the most stressful possible.


1. ATOTW 421 — Perioperative management of suspected/ confirmed cases of COVID-19 (6 April 2020)
2. ANZCA statement on personal protection equipment during the SARS-CoV-2 pandemic (9 April 2020)
3. Russell IF. A comparison of cold, pinprick and touch for assessing the level of spinal block at caesarean section. Int J Obstet Anesth. 2004;13:146–52. [PubMed] [Google Scholar]
Intervention code [1] 317573 0
Treatment: Devices
Intervention code [2] 317584 0
Treatment: Other
Comparator / control treatment
Control group:
As this is a cross over study design, there is no defined control group. All participants will act as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 323781 0
We want to check the amount of time taken to perform each of the two procedures. This will be recorded with a stopwatch. All the data will be collected in a separate sheet and inserted in a computer. We will consider the simulation “PART 3” this moment. It will be counted in minutes and seconds.
Timepoint [1] 323781 0
Recorded from simulation “PART 3” in minutes and seconds
Secondary outcome [1] 382860 0
We want to check the amount of time taken to prepare OT for each technique. This will be recorded with a stopwatch
Timepoint [1] 382860 0
Recorded from simulation “PART 2” in minutes and seconds
Secondary outcome [2] 382861 0
The Decision-to-delivery time interval (DDI). This will be recorded with a stopwatch
Timepoint [2] 382861 0
Recorded from simulation “PART 1 to the end of PART 3” in minutes and seconds
Secondary outcome [3] 382862 0
Measure the level of “stress” caused in each simulation scenario. This will be done with a simple question to the consultant asking him to inform the level of stress of the scenario in a scale of 0 to 10, being “zero” a non- stressful scenario and “ten” the most stressful scenario.
Timepoint [3] 382862 0
At the end of the scenario with a questionnaire

Eligibility
Key inclusion criteria
Consultant anaesthetists who regularly anaesthetise pregnant women requiring category 1 caesarean deliveries and have been doing simulations to deal with COVID – 19 patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to give informed consent.

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)
The order in which each consultant performs the spinal and general anaesthesia simulations will be randomly assigned. An independent person will generate a blocked randomisation sequence using the online “sealed envelope” randomisation software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Blocks of 4 will be created in which the allocation to group A (spinal anaesthesia followed be general anaesthesia simulation) and group B (general anaesthesia followed by spinal anaesthesia simulation) will be determined at random. The Chief investigator will provide the independent person with a list of consultants who will be participating in the simulations, who have provided written consent to participate. The independent person will randomly assign each participant a number between 1 and the total number of participants and sort the list from smallest to largest number. These numbered participants will be assigned in order to the block randomisation list to determine group allocation. The Chief Investigator will then be notified of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation software (https://www.sealedenvelope.com/simple-randomiser/v1/lists).

Sealed Envelope Ltd. Create a blocked randomisation list [Online]. 2019 https://www.sealedenvelope.com/simple-randomiser/v1/lists Date cited 8 Apr 2020
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis plan
All analyses will be primarily conducted in SPSS v19 or later (SPSS, Inc., Chicago, IL) and reported according to the CONSORT guidelines for crossover trials. Baseline data (gender, age, years of experience) will be summarised descriptively and presented in tabular form. Continuous measures will be reported as means and standard deviations, whilst the categorical data will be reported as counts and percentages. Analyses will be conducted following intention-to-treat principles with participants’ outcomes analysed according to their randomised group.

Summary statistics (point and precision estimates) on the within-individual differences in time to perform the two procedures will be reported. The treatment effect and associated precision will be calculated based on within-individual comparisons to capitalise on the gains in precision and statistical efficiency afforded by a crossover design [1]. The tests for significance will be carried out using a paired t-test, based on within participant differences in time taken to perform the procedure [2].

We will use CONSORT guidelines for the analysis and reporting of this crossover trial, which recommends the following for the analysis: [2]
1. Account for the paired in calculating the point estimate of intervention effect, based on the mean for each intervention sequence. Take the difference of the measurement on intervention A minus measurement on intervention B separately for each participant.
2. Account for the paired data nature of crossover trials in calculating the precision (e.g., standard error, confidence interval) of the point estimate of treatment effect, based on a p-value.
3. Present individual patient data for all study groups.
4. Report the results from the first period separately.
A statistician will oversee the analysis as the research team members are not familiar with a paired-sample analysis.

References:
1. Li, T., et al., Design, analysis, and reporting of crossover trials for inclusion in a meta-analysis. PLoS One, 2015. 10(8).
2. Dwan, K., et al., CONSORT 2010 statement: extension to randomised crossover trials. BMJ, 2019. 366: p. l4378.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2020
Actual
3/06/2020
Date of last participant enrolment
Anticipated
1/06/2020
Actual
16/06/2020
Date of last data collection
Anticipated
2/06/2020
Actual
16/06/2020
Sample size
Target
9
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16652 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 30248 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 305714 0
Hospital
Name [1] 305714 0
Mackay Hospital and Health Service
Country [1] 305714 0
Australia
Primary sponsor type
Hospital
Name
Mackay Hospital and Health Service
Address
475 Bridge Rd, Mackay QLD 4740
Country
Australia
Secondary sponsor category [1] 306131 0
None
Name [1] 306131 0
Address [1] 306131 0
Country [1] 306131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305989 0
Human Research Ethics Committee Townsville Hospital and Health Service
Ethics committee address [1] 305989 0
Ethics committee country [1] 305989 0
Australia
Date submitted for ethics approval [1] 305989 0
21/04/2020
Approval date [1] 305989 0
01/05/2020
Ethics approval number [1] 305989 0
63914

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

Contacts
Principal investigator
Name 102330 0
Dr Marcelo Epsztein Kanczuk
Address 102330 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 102330 0
Australia
Phone 102330 0
+61 439392734
Fax 102330 0
Email 102330 0
marcelokanc@gmail.com
Contact person for public queries
Name 102331 0
Marcelo Epsztein Kanczuk
Address 102331 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 102331 0
Australia
Phone 102331 0
+61 439392734
Fax 102331 0
Email 102331 0
marcelokanc@gmail.com
Contact person for scientific queries
Name 102332 0
Marcelo Epsztein Kanczuk
Address 102332 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 102332 0
Australia
Phone 102332 0
+61 439392734
Fax 102332 0
Email 102332 0
marcelokanc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data will not have value for other studies.


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
SourceTitleYear of PublicationDOI
EmbaseThe time to perform spinal or general anaesthesia in COVID-19 positive parturients requiring emergency caesarean delivery: A prospective crossover simulation study.2021https://dx.doi.org/10.31083/j.ceog4805177
N.B. These documents automatically identified may not have been verified by the study sponsor.