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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: high flow nasal cannula (HFNC)
* Procedure: Prone positioning (PP)


Participation Criteria
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Eligibility Criteria
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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: 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); Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change); unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor); unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP. chest trauma or any contraindication for PP pneumothorax age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high flow nasal cannula only<br>Receive high flow nasal cannula only | Device: high flow nasal cannula (HFNC)<br>* 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.<br>|
| Experimental: HFNC plus prone positioning<br>Receive high flow nasal cannula plus prone positioning | Device: high flow nasal cannula (HFNC)<br>* 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.<br>Procedure: Prone positioning (PP)<br>* 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%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure (Intubation or Death) | the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment | 28 days | 
| Number of Participants With Intubation | intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment | 28 days | 
| Mortality | mortality of HFNC/HFNC+PP support within 28 days of study enrollment | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest | 28 days of study enrollment |