NCT04632043

Early Versus Delayed Intubation of Patients With COVID-19

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Evangelismos Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Acute Hypoxemic Respiratory Failure

Interventions

Type	Name	Description
OTHER	Endotracheal intubation	Endotracheal intubation

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2020-11-17
• Last updated: 2024-02-20

Locations

1 site across 1 country: Greece