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

Last updated: August 14, 2020
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Covid-19

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT04391140
PR(AG)198/2020
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • COVID-19 pneumonia according to the diagnostic criteria in effect at the time ofinclusion or very strongly suspected.

  • Patient treated by nasal high flow.

  • Moderate or severe ARDS: bilateral radiological opacities not explained entirely byeffusions, atelectasis or nodules; acute hypoxemia with worsening within the 7previous 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

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

Study Design

Total Participants: 248
Study Start date:
May 13, 2020
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

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