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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391140
• Other study ID #: PR(AG)198/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• ARDS
• Corona Virus Infection
• Coronavirus Infections
• COVID
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic failure death or intubation	Therapeutic failure: death or intubation	28 days within randomization
Secondary	Feasibility and safety of prone position in HFNC patients	Comfort measurement using a visual-analog scale.; Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers.; Intravascular lines displacement; HFNC related events (hot air feeling, nasal lesions)	28 days within randomization
Secondary	Efficacy of prone position in HFNC patients	Evolution of the oxygenation (SpO2/FiO2) in prone position.; Efficacy; Length of HFNC therapy; Length of ICU stay; Length of mechanical ventilation (in those who require intubation); ICU and hospital mortality	28 days within randomization