Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Hospital St. Joseph, Marseille, France
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- [PaO2 / FiO2] ratio
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.
Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.
Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥ 18 years,
- •Admitted to ICU within 72 hours,
- •Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
- •Having acute hypoxemic respiratory failure with a \[PaO2/FiO2\] ratio between 100 mmHg and 300 mmHg,
- •Having given free and informed written consent,
- •Being affiliated with or benefiting from a social security scheme.
Exclusion Criteria
- •Unable to achieve a prone position for mobility reasons,
- •Unable to achieve a prone position due to agitation whatever the cause,
- •With clinical occlusive syndrome in order to limit the risk of inhalation,
- •Having a contraindication to the use of the esophageal catheter,
- •Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
- •Having hypercapnia indicating the use of non-invasive ventilation (PaO2\> 50 mmHg),
- •Having severe hypoxemia defined by PaO2 / FiO2 \<100mmHg,
- •Ongoing pregnancy or breastfeeding,
- •Subject to a measure for the protection of justice.
Outcomes
Primary Outcomes
[PaO2 / FiO2] ratio
Time Frame: 6 hours
Oxygenation will be evaluated by the \[PaO2 / FiO2\] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.
Secondary Outcomes
- ΔPeso measured using an esophageal balloon catheter(6 hours)
- Tolerance of the technique(6 hours)
- Intensity of dyspnea(6 hours)
- Concentration of CO2 at the end of expiration (EtCO2, mmHg)(6 hours)
- The occurrence of side effects due to PP(6 hours)