Clinical trial NCT04325906: Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS
Official title: Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Positioning
High Flow Nasal Cannula
Acute Respiratory Distress Syndrome
Corona Virus Infection
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment Failure (Intubation or Death)
timeFrame: 28 days
measure: Number of Participants With Intubation
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 28 days of study enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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