EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEvangelismos Hospital
About this trial
We attempt to perform dynamic endotyping of critically ill patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). We also attempt to identify what clinical, radiological, physiological and biological variables collected early in the course of AHRF correlate with subsequent mortality and/or persistent severe hypoxemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged >18 years) presenting in the emergency department
De novo acute hypoxemic respiratory failure (requiring oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more)
Disqualifiers
Age <18 years
Not admitted to the hospital
Postoperative acute respiratory failure (within one week from surgery)
Chronic hypoxemic respiratory failure (requiring long term oxygen therapy at home)
Trial population
Patients presenting in the emergency department with de novo acute hypoxemic respiratory failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: Patients with de novo acute hypoxemic respiratory failure
Trial outcomes
Primary outcomes
1
Identification of dynamic endotypes of acute hypoxemic respiratory failure
Mutually exclusive subgroups of patients (clusters) characterized by a distinct biological profile that might share mortality risk, clinical course, and/or treatment responsiveness.
Time frame
Until death or hospital discharge, assessed up to 28 days following presentation to the emergency departmentSecondary outcomes
1
All-cause mortality
To determine what variables among those collected, including protein biomarkers, are associated with subsequent all-cause mortality.
Time frame
Until death or hospital discharge, assessed up to 28 days following presentation to the emergency department2
Persistent severe hypoxemia
To determine what variables among those collected, including protein biomarkers, are associated with persistent severe hypoxemia. We will consider that persistent severe hypoxemia is present in endotracheally intubated individuals receiving positive pressure ventilation and having a PaO2:FiO2 ratio of equal to or less than 100 mmHg at 48 hours following intubation.
Time frame
Until 28 days following presentation to emergency department3
Intensive care unit-free days
Intensive care unit-free days are calculated by the number of days in the first 28 days following presentation in the emergency department that a patient is alive and not in the intensive care unit.
Time frame
Until 28 days following presentation to emergency department4
Vasopressor-free days
Vasopressor-free days are calculated by the number of days in the first 28 days following presentation in the emergency department that a patient is alive and not receiving vasopressors.
Time frame
Until 28 days following presentation to emergency departmentSponsors and contacts
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Source ClinicalTrials.gov