High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;

Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;

PaCO2 ≤ 45 mmHg;

Disqualifiers

Acute asthma or COPD exacerbation,

Cardiac failure or fluid overload as primary cause of respiratory failure;

Unstable angina or ongoing acute myocardial infarction;

Acute respiratory acidosis with pH < 7.35 and PaCO2 > 45 mmHg;

Trial design

Design model

Parallel

Treatments tested in this trial

  • high flow nasal cannula

    Device

    humidified and heated oxygen

  • standard oxygen

    Other intervention

    oxygen delivery through Venturi mask

Treatment groups

234 Participants
are divided into 2 treatment groups
Group A: standard oxygenActive comparator 1 intervention
Group B: high flow nasal oxygenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Early deterioration

occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.

Time frame
24 hours

Secondary outcomes

1

Development of respiratory acidosis

arterial pH

Time frame
2, 12 and 24 hours
2

Development of hypercapnia

arterial pCO2

Time frame
2, 12 and 24 hours
3

Worsening hypoxemia

P/F ratio

Time frame
2, 12 and 24 hours
4

Worsening respiratory distress

respiratory frequency

Time frame
2, 12 and 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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