Moderate-to-severe acute hypoxemic respiratory failure due to COVID-19 pneumonia Respiratory
Conditions
Interventions
In both arms, patients receive noninvasive ventilation (NIV) for at least 16 hours/day during at least the first 2 calendar days. Continuous NIV without interruptions in the first 24 hours of treat
otherwisw, weaning from NIV is started.
Experimental arm
Patients of the experimental (prone position, PP) qrm will be asked to remain in prone position (i.e. lying straight on the stomach) throu
Sponsors
Ospedale Humanitas Gradenigo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of acute (i.e. symptom onset <14 days of hospital access) hypoxemic respiratory failure 2. Confirmed severe SARS-CoV-2 pneumonia based on the Center for Disease Control guidelines: SARS-CoV-2 infection confirmed by PCR AND bilateral opacities on chest X-ray or CT scan not fully explained by effusions, lobar or lung collapse, or nodules, with sO2<90% in room air on pulse oxymetry 4. Cardiac failure not the primary cause of acute respiratory failure 5. Moderate to severe hypoxemia, defined by a PaO2/FiO2 ratio <200 mm Hg while receiving oxygen therapy through either a Venturi mask with FiO2 50% or a non-rebreather reservoir bag-mask, with FiO2 estimated as 0.21+ oxygen flow rate in L/min×3
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years-old 2. Pregnancy 3. Immediate need of invasive mechanical ventilation (altered mental status, fatigue, hemodynamic instability). 4. Contraindications for prone positioning therapy (recent abdominal or thoracic surgery or wound; facial, pelvic, or spine fracture) 5. Vomiting or bowel obstruction 6. Palliative care 7. Multiorgan failure 8. Pneumothorax 9. Inability of the patient to provide informed consent 10. Uncooperativeness or refusal to lie on abdomen for at least 8 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of NIV failure at 28 days, defined as the occurrence of endotracheal intubation (for those patients with a full treatment indication) OR death for those patients with a Do-Not-Intubate (DNI) order. This will be assessed by reviewing patient notes or in-presence or phone patient interview. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/10/2021: Secondary clinical outcomes censored at 28 days after enrolment from patient records were: 1. Death 2. Intubation (after excluding patients with a do-not-intubate, DNI, order) 3. Time to NIV failure/intubation/death 4. Daily hours of PP therapy 5. Duration of the longest PP session each day 6. Total number of PP sessions each day 7. Daily hours of NIV 8. Days of PP therapy 9. Days of NIV 10. Length of Subintensive Care Unit/hospital stay 11. Days of invasive mechanical ventilation 12. Death in invasively mechanically ventilated patients 13. Device-related discomfort and dyspnoea: via the Numeric Pain Rating Scale(NRS) and the Critical-Care Pain Observation Tool(CPOT), respectively 14. Predefined safety outcomes as prospectively recorded by investigators The following outcomes were recorded during the initial 7 days after enrollment to explore physiological response to PP (physiological substudy): 1. Lung ultrasound (LUS) indices of lung aeration and recruitment assessed at baseline (within 24 hrs of enrollment) and at day 5 (details of the assessment and justification of the timing are 2. paO2/FiO2 ratio, pCO2, respiratory rate (RR) obtained from ABG drawn 1 hour after initiating NIV in supine position, 1 hour after starting the 8-hr PP session and 1 hour after resupination following the 8-hr PP session. RR and VTe were recorded at the time of each ABG. 3. Physiological dead space indices(DSIs): Ventilatory Ratio(VR) and corrected Minute Ventilation (MVcorr). 4. Change in 18 blood laboratory parameters from admission to day 7, including inflammatory and procoagulative biomarkers. ______ Previous secondary outcome measures: 1. The need for endotracheal intubation at 28 days among patients with a full treatment indication. This will be assessed by reviewing patient notes or in-presence or phone patient interview. 2. Mortality at 28 days. This will be assessed by reviewing patient notes or in-presen | — |
Countries
Italy
Outcome results
None listed