Acute Respiratory Distress Syndrome, Acute Respiratory Failure, ARDS, Corona Virus Infection, COVID
Conditions
Keywords
PRONE POSITION, High flow nasal cannula
Brief summary
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
Interventions
OTHERProne position
HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected. * Patient treated by nasal high flow. * Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio \<300 mmHg (or SpO2 / FiO2 equivalent). * Informed consent. * Beneficiary or affiliated to a social security scheme.
Exclusion criteria
* Indication of immediate tracheal intubation * Significant acute progressive circulatory insufficiency * Impaired alertness, confusion, restlessness * Body mass index\> 40 kg / m2 * Chest trauma or other contraindication to prone position * Pneumothorax * Vulnerable person: safeguard of justice * Pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic failure death or intubation | 28 days within randomization | Therapeutic failure: death or intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and safety of prone position in HFNC patients | 28 days within randomization | 1. Comfort measurement using a visual-analog scale. 2. Presence of complications related with prone position and the use of high-flow nasal cannula: 1. Skin ulcers. 2. Intravascular lines displacement 3. HFNC related events (hot air feeling, nasal lesions) |
| Efficacy of prone position in HFNC patients | 28 days within randomization | 1. Evolution of the oxygenation (SpO2/FiO2) in prone position. 2. Efficacy 1. Length of HFNC therapy 2. Length of ICU stay 3. Length of mechanical ventilation (in those who require intubation) 4. ICU and hospital mortality |
Countries
Spain
Outcome results
None listed