Covid-19 Airway Management

Covid-19_airways Management Clinical Trial

Official title:

Determining Airway Management Related Outcomes in COVID19 Patients and in Health Care Providers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689724
• Other study ID #: 20-5620
• Status: Completed
• Start date: August 10, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: December 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study has a retrospective and a prospective component. The retrospective component aims to review data of all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. The prospective component aims to assess the incidence of COVID-19 infection in Airway Management Team members by means of an interview assessing their COVID19 status after participating in airway management in the period outlined above. This prospective interview component is starting in December 2020.

Description:

Approximately 5-10% of all patients affected by COVID-19 develop severe respiratory distress. This has already involved hundreds of people in Ontario and thousands worldwide. In this situation, support with a mechanical ventilator is required. The first essential step to provide this support is to insert a breathing tube in the patent's trachea (windpipe), a process called 'endotracheal intubation' or more broadly, 'airway management'. While a fundamental lifesaving resource, endotracheal intubation in COVID-19 patents is a highly specialized procedure that carries risk both to patents and attending healthcare providers as follows. a) Clinicians involved in airway management for patients with coronaviruses are at extremely high risk of infection due to aerosol and droplet exposure during the procedure. b) Rapid administration of drugs that put the patent to sleep is usually required for prompt and safe endotracheal intubation. However, in physiologically compromised patents, life-threatening side-effects may occur, such as very low oxygen levels (in as many as 70% of patients), low blood pressure (18-22% of patients), and cardiac arrest (2%); these can significantly affect outcomes. No definitive data are presently available to accurately quantify the risk posed by such procedures to healthcare professionals and patents, nor the associated factors. We have developed a retrospective study reviewing data all airway management related SAEs in COVID 19 patients (between April and July 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. Additionally, we are going to prospectively interview Airway Management Team members that were involved in the airway management of COVID19 patients in the period described above, in order to assess whether they developed signs and symptoms and/or a confirmed COVID19 infection. This prospective interview component is starting in December 2020.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All Suspected or confirmed Covid-19 patients that require intubation Health care workers from the airways management team who performed an intubation on confirmed or suspected Covid-19 patients

Exclusion Criteria:

Lack of Health Care Provider Consent

Related Conditions & MeSH terms

• COVID-19
• Covid-19_airways Management

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Jarvis N, Schiavo S, Bartoszko J, Ma M, Chin KJ, Parotto M. A specialized airway management team for COVID-19 patients: a retrospective study of the experience of two Canadian hospitals in Toronto. Can J Anaesth. 2021 Dec 8. doi: 10.1007/s12630-021-02169- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse events at intubation	hypoxemia, hypotension and cardiac arrest within 15 min of intubation in confirmed or suspected COVID-19 patients	within 15 min of intubation
Secondary	Signs, symptoms or confirmed COVID19 infection in healthcare providers	via an interview exploring past events, we will assess whether providers recall having developed signs, symptoms or confirmed COVID19 infection after participating in airway management for confirmed or suspected COVID-19 patients	within 14 days after participating in airway management for confirmed or suspected COVID-19 patients