Clinical trial NCT04543760: Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: [PaO2 / FiO2] ratio
timeFrame: 6 hours
Secondary outcomes:
measure: ΔPeso measured using an esophageal balloon catheter
timeFrame: 6 hours
measure: Concentration of CO2 at the end of expiration (EtCO2, mmHg)
timeFrame: 6 hours
measure: Intensity of dyspnea
timeFrame: 6 hours
measure: Tolerance of the technique
timeFrame: 6 hours
measure: Tolerance of the technique
timeFrame: 6 hours
measure: The occurrence of side effects due to PP
timeFrame: 6 hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Européen
city: Marseille
country: France
facility: Hopital La Timone
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: Hopital Nord
Study officials:
affiliation: Hopital Saint Joseph Marseille
name: Samuel LEHINGUE, M.D
role: PRINCIPAL_INVESTIGATOR
References: