Respiratory Distress Syndrome, Adult
Conditions
Brief summary
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.
Interventions
DEVICEhigh flow nasal cannula
humidified and heated oxygen
OTHERstandard oxygen
oxygen delivery through Venturi mask
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
* 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; * Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.
Exclusion criteria
* Respiratory failure due to: * 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; * Hemodynamic instability and/or use of vasopressors/inotropes; * Altered mental status (Kelly \>3), see Figure 1;(18) * Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds); * Indications to urgent intubation performed according to the clinician in charge; * Body Mass Index \> 35 kg/m2; * Pregnancy; * Patient's refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early deterioration | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of hypercapnia | 2, 12 and 24 hours | arterial pCO2 |
| Worsening hypoxemia | 2, 12 and 24 hours | P/F ratio |
| Worsening respiratory distress | 2, 12 and 24 hours | respiratory frequency |
| duration of any type of ventilatory support | 90 days | hours of ventilatory support |
| rate of ICU admission | 90 days | number of patients admitted to ICU |
| hospital length-of-stay | 30 days | duration of hospitalization |
| in-hospital mortality | 90 days | death during hospitalization |
| Development of respiratory acidosis | 2, 12 and 24 hours | arterial pH |
| ICU mortality | 90 days | death in ICU |
| development of complications | 90 days | composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium |
| level of dyspnea | 24 hours | utilizing Borg scale |
| patient comfort | 24 hours | utilizing visual analogue scale |
| clinical setting after ED stabilization | 24 hours | type of ward admission |
| standard vs asymmetrical high-flow nasal cannula | 24 hours | rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula |
| ICU length-of-stay | 90 days | duration of ICU stay |
Contacts
Primary ContactFrancesco Franceschi, MD
Backup ContactGianluca Tullo, MD
Outcome results
None listed