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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type OTHER

Prone position

Intervention Type OTHER

prone positioning in spontaneous ventilation

Supine position

Intervention Type OTHER

supine positiong in spontaneous ventilation

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

Group Type OTHER

Prone position

Intervention Type OTHER

prone positioning in spontaneous ventilation

Supine position

Intervention Type OTHER

supine positiong in spontaneous ventilation

Interventions

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Prone position

prone positioning in spontaneous ventilation

Intervention Type OTHER

Supine position

supine positiong in spontaneous ventilation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No