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Clinical Trials/NCT04689724
NCT04689724
Completed
Not Applicable

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

University Health Network, Toronto1 site in 1 country123 target enrollmentAugust 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid-19_airways Management
Sponsor
University Health Network, Toronto
Enrollment
123
Locations
1
Primary Endpoint
Serious adverse events at intubation
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2020
End Date
October 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matteo Parotto

Dr. Matteo Parotto

University Health Network, Toronto

Eligibility Criteria

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

Outcomes

Primary Outcomes

Serious adverse events at intubation

Time Frame: within 15 min of intubation

hypoxemia, hypotension and cardiac arrest within 15 min of intubation in confirmed or suspected COVID-19 patients

Secondary Outcomes

  • Signs, symptoms or confirmed COVID19 infection in healthcare providers(within 14 days after participating in airway management for confirmed or suspected COVID-19 patients)

Study Sites (1)

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