NCT04325906

Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2020-04-02
• Primary completion: 2021-01-26
• Completion: 2021-02-21
• First posted: 2020-03-30
• Last updated: 2022-03-02
• Results posted: 2022-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study