Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000617965
Ethics application status
Approved
Date submitted
14/05/2020
Date registered
27/05/2020
Date last updated
27/05/2020
Date data sharing statement initially provided
27/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-site audit of COVID-19 airway interventions
Scientific title
Airway Interventions in Suspected and Confirmed COVID-19 cases: An audit of personal protective equipment (PPE) use, protocol adherence and procedural outcomes
Secondary ID [1] 301274 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway procedures 317452 0
Covid-19 317485 0
Condition category
Condition code
Anaesthesiology 315550 315550 0 0
Anaesthetics
Respiratory 315586 315586 0 0
Other respiratory disorders / diseases
Infection 315587 315587 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Following the 2019 outbreak in Wuhan, China of a novel coronavirus named severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) we have witnessed the most significant pandemic of our lifetime – COVID 19.

For the majority, a mild self-limiting febrile illness ensues, however in 14-17% of cases, acute respiratory distress syndrome (ARDS) develops & 5% suffer from septic shock and/or multiple organ dysfunction. (1-2) Early data from Wuhan & Italy suggested approximately 10% of COVID-19 cases require intensive care management with many requiring urgent tracheal intubation & mechanical ventilation. (2)

Transmission of COVID-19 is primarily through droplet & fomite spread. (3-4)

Ø Droplets are larger particles of body fluids that travel only a short distance through air before landing on surrounding surfaces

Ø Fomites are surfaces contaminated by virus which may remain active for hours to days

Ø Aerosols are much smaller fluid particles that remain suspended in the air for prolonged periods increasing risk of transmission. This remains plausible for COVID-19, however doesn’t seem to be the main route of community transmission.

During the SARS-CoV-2 outbreak in 2003, half of all cases were nosocomial transmission to healthcare workers. (5) Similarly, COVID-19 has been classified a high-risk infectious disease with significant risk to healthcare workers. Aerosol generating events are those that can potentially lead to aerosolization of virally contaminated body fluid and therefore transmission of disease. Such events include: Positive pressure ventilation during non-invasive ventilation or when using a face mask or supraglottic airway, laryngoscopy, tracheal intubation/extubation & bronchoscopy if coughing is precipitated. (6)

Airway management is a high-risk period for aerosol based transmission due to: (6)

Ø Patient agitation due to hypoxia

Ø Patient’s mask must be removed

Ø Clinician near patient’s airway

Ø Laryngoscopy & intubation/extubation are vulnerable to aerosol generation

Ø Aerosol generating events more likely

In response, several strategies for safe airway management have been proposed including the use of full personal protective equipment, modified intubation & extubation techniques limiting potential aerosalisation, formation of COVID intubation teams with an experienced intubator on-site 24 hours a day. These strategies are largely based on general consensus or expert option rather then high quality evidence, such is the nature of acute pandemics with little time to research efficacy of protective measures.

We will be auditing whether all PPE was available to the intubating team; including: double gloves, N95/P2 masks, face shields, alcohol hand wash, surgical gowns, shoe protectors, hair covers and powered air purifying respirators. Further, details of the intubating episode, including; experience and specialty of the clinician, device(s) used, number of attempts, adjunct procedures/devices will be recorded. Lastly, a record of complications, including desaturation, hypotension, cardiac arrest, breach in PPE, airway circuit problems, aspiration, and gross contamination of staff will be recorded. Written feedback will be reviewed with each audit-form submission to ensure unsafe airway intervention practices can be reduced.

The duration of this study will be twelve months.

1. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.

2. Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-13.

3. Centre for Disase Control. Environmental Cleaning and Disinfection Recommendations: Interim Recommendations for US Households with Suspected/Confirmed Coronavirus Disease 2019. Accessed March 13, 2020 at https://www.cdc.gov/coronavirus/2019-ncov/community/home/cleaning-disinfection.html.

4. Van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, et al. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. New England Journal of Medicine. March 17 2020; DOI: 10.1056/NEJMc2004973

5. Parodi SM, Liu VX. From Containment to Mitigation of COVID-19 in the US. JAMA. Published online March 13, 2020. doi:10.1001/jama.2020.3882

6. Brewster DJ, Chrimes NC, Do TBT, Fraser K, Groombridge CJ, Higgs A, et al. Consensus statement: Safe Airway Society principles of airway management and tracheal intubation specific to the COVID-19 adult patient group. Medical Journal of Australia. Published online March 16 2020.
Intervention code [1] 317579 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323793 0
Assessment of PPE use
- this will be assessed via the study audit form; completed by intubating clinicians following each intervention. Clinicians will indicate all of the PPE available to them and used in the procedure.
Timepoint [1] 323793 0
The intervention will be assessed immediately following each episode of airway management.
Primary outcome [2] 323896 0
Adherence to COVID-19 airway intervention protocols
- this will be assessed via the study audit form; completed by intubating clinicians following each intervention. Clinicians will indicate the number of attempts and details of procedure.
Timepoint [2] 323896 0
The intervention will be assessed immediately following each episode of airway management.
Secondary outcome [1] 382916 0
Examine the indications for airway intervention
- this will be assessed via the study audit form; completed by intubating clinicians following each intervention. Clinicians will select the indication for their airway intervention.
Timepoint [1] 382916 0
Following each episode of airway management, the audit form will be completed. This outcome will be assessed immediately after the intervention.
Secondary outcome [2] 382917 0
Assess for major complications of airway intervention
- this will be assessed via the study audit form; completed by intubating clinicians following each intervention. Clinicians will nominate any of the complications encountered.
Timepoint [2] 382917 0
Following each episode of airway management, the audit form will be completed. This outcome will be assessed immediately after the intervention.
Secondary outcome [3] 382918 0
Determine the availability of personal protective equipment (PPE) during airway intervention.
Timepoint [3] 382918 0
Following each episode of airway management, the audit form will be completed. This outcome will be assessed immediately after the intervention.
Secondary outcome [4] 382920 0
Assess the feedback on the process to implement changes promoting staff safety during these high risk procedures.
Feedback will be categorised as 'PPE feedback', 'process feedback', 'device feedback' and 'other feedback'. This feedback will be provided to the participating departments for review and consideration of process improvement.
Timepoint [4] 382920 0
Following each episode of airway management, the audit form will be completed. Feedback will be compiled immediately after the intervention.

Eligibility
Key inclusion criteria
Medical practitioner performing airway intervention on confirmed or suspected COVID19 patient within a participating hospital.
Minimum age
23 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/04/2020
Date of last participant enrolment
Anticipated
27/03/2021
Actual
Date of last data collection
Anticipated
28/03/2021
Actual
Sample size
Target
100
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305720 0
Hospital
Name [1] 305720 0
St. Vincent's Hospital, Sydney
Country [1] 305720 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 306140 0
None
Name [1] 306140 0
Address [1] 306140 0
Country [1] 306140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305996 0
St Vincent's Hospital HREC
Ethics committee address [1] 305996 0
Ethics committee country [1] 305996 0
Australia
Date submitted for ethics approval [1] 305996 0
Approval date [1] 305996 0
30/04/2020
Ethics approval number [1] 305996 0

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

Contacts
Principal investigator
Name 102354 0
Dr Erez Ben-Menachem
Address 102354 0
Anaesthetics Department
St. Vincent's Hospital
390 Victoria St
Darlinghurst NSW
2010
Country 102354 0
Australia
Phone 102354 0
+61 0283821111
Fax 102354 0
Email 102354 0
erezben@yahoo.com
Contact person for public queries
Name 102355 0
Erez Ben-Menachem
Address 102355 0
Anaesthetics Department
St. Vincent's Hospital
390 Victoria St
Darlinghurst NSW
2010
Country 102355 0
Australia
Phone 102355 0
+61 0283821111
Fax 102355 0
Email 102355 0
erezben@yahoo.com
Contact person for scientific queries
Name 102356 0
Erez Ben-Menachem
Address 102356 0
Anaesthetics Department
St. Vincent's Hospital
390 Victoria St
Darlinghurst NSW
2010
Country 102356 0
Australia
Phone 102356 0
+61 0283821111
Fax 102356 0
Email 102356 0
erezben@yahoo.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 study is an audit of airway management processes. It is being undertaken to review the safety and improve outcomes for patients and medical staff involved in intubation of suspected or confirmed COVID19 patients.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes A multicentre audit of COVID-19 intubations in New... [More Details] 379824-(Uploaded-29-04-2021-17-45-57)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.