Official Title
Effect of Early versUs Delayed intubatiOn on Clinical Outcomes of Patients With COVID-19 (EUDOCO): a Feasibility Randomized Controlled Trial
Brief Summary

Although management of acute hypoxemic respiratory failure associated with coronavirus disease 2019 (COVID-19) often includes mechanical ventilation, the optimal timing of initiation of invasive mechanical ventilation remains unknown. We hypothesise that a randomized controlled trial comparing early intubation as opposed to delayed intubation among patients with COVID-19 suffering from severe acute hypoxemic respiratory failure is feasible.

Detailed Description

A common manifestation of COVID-19 is severe acute hypoxemic respiratory failure. Management
of acute hypoxemic respiratory failure associated with COVID-19 often includes mechanical
ventilation. The optimal timing of initiation of invasive mechanical ventilation remains
unknown.

On the one hand, early initiation of invasive mechanical ventilation (i.e. early endotracheal
intubation) has been advocated as a means to reduce subsequent possible aerosolization of the
virus, as would happen by alternate means of oxygenation/ventilation allowing air leaks.
Also, early intubation may prevent the induction of self-inflicted lung injury in patients
who breath spontaneously and have high respiratory drive and, therefore, large transpulmonary
pressure swings. On the other hand, delaying intubation, by trying alternate means of
oxygenation/ventilation, may mean that some of the patients may not be intubated at all and
therefore will be protected from the adverse events of invasive mechanical ventilation (such
as ventilator-induced lung injury, ventilator-associated pneumonia and ventilator-induced
diaphragmatic dysfunction). The latter strategy may also address the unavailability of enough
ventilators to meet the increased demand of treating patients with COVID-19.

Given that no randomized controlled trials are currently available to guide clinical practice
regarding optimal timing of intubation, we propose a single-center randomized controlled
feasibility trial to compare early intubation versus delayed intubation among patients with
COVID-19 suffering from severe acute hypoxemic respiratory failure. The aim is that we gain
experience and produce pilot data, which could inform the design of a subsequent large
multi-center clinical trial.

Unknown status
COVID-19
Acute Hypoxemic Respiratory Failure

Other: Endotracheal intubation

Endotracheal intubation

Eligibility Criteria

Inclusion Criteria:

Adult patients with confirmed COVID-19 and severe acute hypoxemic respiratory failure

Exclusion Criteria:

- Postoperative acute respiratory failure (within one week from surgery)

- After cardiac arrest

- Chronic hypoxemic respiratory failure

- Hypercapnic respiratory failure

- No full code

- Lack of equipoise of the clinical team

- Lack of informed consent

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Greece
Locations

Evangelismos Hospital
Athens, Attiki, Greece

Investigator: Ilias Siempos, MD, DSc
Contact: +306948279049
isiempos@yahoo.com

Contacts

Ilias Siempos, MD, DSc
+306948279049
isiempos@yahoo.com

Ilias Siempos, MD, DSc, Principal Investigator
Evangelismos Hospital

Evangelismos Hospital
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Respiratory Insufficiency