Covid-19 Airway Management

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

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.

Study Overview

• Status: Completed
• Conditions: Covid-19_airways Management

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will use exclusively retrospective data from suspected or positive COVID-19 adult patients who required intubation during their hospital stay and also record the rate of infection in HCP who perform the intubation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Matteo Parotto, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• 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. 2022 Mar;69(3):333-342. doi: 10.1007/s12630-021-02169-x. Epub 2021 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-5620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No