Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID ARDS Acute Respiratory Distress Syndrome Acute Respiratory Failure Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

Combination of prone position and HFNC

Group Type EXPERIMENTAL

Prone position

Intervention Type OTHER

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.

Control

Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prone 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No