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Multi-site audit of COVID-19 airway interventions

Airway Interventions in Suspected and Confirmed COVID-19 cases: An audit of personal protective equipment (PPE) use, protocol adherence and procedural outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000617965
Enrollment
25
Registered
2020-05-27
Start date
2020-04-30
Completion date
2021-03-27
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The safety of staff during high risk aerosol generating procedures such as airway intervention is paramount. Currently, there is no high-quality evidence or standards available, with the current process for airway intervention based on experiences with SARS & COVID19 in other countries. We are currently auditing our internal process however acknowledging our numbers are low, we have reached out to other hospitals in NSW. The goal is to combine survey data with other hospital sites in NSW to analyse a larger dataset to draw more meaningful conclusions. The goal is to address any weaknesses in our safety process of PPE & intubation technique to ensure staff safety.

Interventions

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 COVI

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.

Sponsors

St. Vincent's Hospital, Sydney
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
23 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Medical practitioner performing airway intervention on confirmed or suspected COVID19 patient within a participating hospital.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026