Early Versus Delayed Intubation of Patients With COVID-19 (EUDOCO)
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|ClinicalTrials.gov Identifier: NCT04632043|
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : March 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Acute Hypoxemic Respiratory Failure||Other: Endotracheal intubation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Early versUs Delayed intubatiOn on Clinical Outcomes of Patients With COVID-19 (EUDOCO): a Feasibility Randomized Controlled Trial|
|Actual Study Start Date :||November 18, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Active Comparator: Early intubation
Patients with COVID-19 suffering from severe acute hypoxemic respiratory failure (defined as the need for non-rebreather mask or high flow nasal oxygen with setting FiO2 of at least 90% or non-invasive mechanical ventilation to maintain a SpO2 >92%) for at least 48 hours will undergo intubation.
Other: Endotracheal intubation
Active Comparator: Delayed intubation
Patients with COVID-19 suffering from severe acute hypoxemic respiratory failure (defined as the need for non-rebreather mask or high flow nasal oxygen with setting FiO2 of at least 90% or non-invasive mechanical ventilation to maintain a SpO2 >92%) for at least 48 hours will continue to receive non-rebreather mask, high-flow nasal oxygen or non-invasive mechanical ventilation in an attempt to avoid intubation.
Other: Endotracheal intubation
- Time from onset of severe acute hypoxemic respiratory failure to intubation [ Time Frame: 28 days ]Difference in time from onset of severe acute hypoxemic respiratory failure to intubation between the two groups will be the primary (feasibility) outcome
- Organ failure-free days [ Time Frame: 28 days ]Number of days without the need for invasive mechanical ventilation, vasopressors and continuous renal replacement therapy with days after death not to be considered as organ failure-free days
- Need for continuous renal replacement therapy [ Time Frame: 28 days ]
- Ventilator-free days [ Time Frame: 28 days ]
- ICU-free days [ Time Frame: 28 days ]Intensive care unit-free days
- Mortality [ Time Frame: 28 days ]All-cause ICU-mortality
- Number of severe post-intubation adverse events [ Time Frame: Within 30 minutes from intubation ]Cardiac arrest and severe arterial desaturation (defined as SpO2 <80% for >5 minutes)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632043
|Contact: Ilias Siempos, MD, DScfirstname.lastname@example.org|
|Athens, Attiki, Greece, 10676|
|Contact: Ilias Siempos, MD, DSc +306948279049 email@example.com|
|Principal Investigator:||Ilias Siempos, MD, DSc||Evangelismos Hospital|