Acute Hypoxemic Respiratory Failure, COVID-19
Conditions
Keywords
COVID-19
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.
Interventions
OTHEREndotracheal intubation
Endotracheal intubation
Sponsors
Evangelismos Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from onset of severe acute hypoxemic respiratory failure to intubation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for continuous renal replacement therapy | 28 days | — |
| Ventilator-free days | 28 days | — |
| Organ failure-free days | 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 |
| Mortality | 28 days | All-cause ICU-mortality |
| Number of severe post-intubation adverse events | Within 30 minutes from intubation | Cardiac arrest and severe arterial desaturation (defined as SpO2 \<80% for \>5 minutes) |
| ICU-free days | 28 days | Intensive care unit-free days |
Countries
Greece
Outcome results
None listed