Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19 (DeCOPO)

Hospital Saint Joseph

Status: Completed

Conditions: Covid19

Treatments: Other: Prone position; Other: Supine position

Study type: Interventional

Funder types: Other

Identifiers

NCT04543760

2020-04-03

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

[PP sequence 1] - Wash-out - [SP sequence 2]

Other group

Treatment:

Other: Supine position

Other: Prone position

[SP sequence 1] - Wash-out - [PP sequence 2]

Other group

Treatment:

Other: Supine position

Other: Prone position