Official Title
Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
Brief Summary

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.

Completed
Prone Positioning
High Flow Nasal Cannula
Acute Respiratory Distress Syndrome
Corona Virus Infection

Device: high flow nasal cannula (HFNC)

HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.

Procedure: Prone positioning (PP)

PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%.

Eligibility Criteria

Inclusion Criteria:

- COVID-19 induced adult ARDS patients admitted to the medical ICU

- PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on
HFNC treatment

Exclusion Criteria:

1. If the patients have a consistent SpO2<80% when on evaluation with a FiO2 of 0.6, or
signs of respiratory fatigue (RR > 40/min, PaCO2> 50mmHg / pH<7.30, and obvious
accessory respiratory muscle use);

2. Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect
airway or mental status change);

3. unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for
vasopressor);

4. unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.

5. chest trauma or any contraindication for PP

6. pneumothorax

7. age < 18 years

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Rush University Medical Center
Chicago, Illinois, United States

Jie Li, PhD, Principal Investigator
Rush University Medical Center

Rush University Medical Center
NCT Number
MeSH Terms
Coronavirus Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury