N/A
N=224
Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS
Prone Positioning · High Flow Nasal Cannula · Acute Respiratory Distress Syndrome · Corona Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04325906 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Treatment Failure (Intubation or Death) — 45; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- high flow nasal cannula (HFNC) (Device); Prone positioning (PP) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure (Intubation or Death) |
45; 45 | — |
| PRIMARY Number of Participants With Intubation |
39; 38 | — |
| PRIMARY Mortality |
30; 21 | — |
| SECONDARY Number of Participants With Adverse Events |
0; 2 | — |
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
- If the patients have a consistent SpO2 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
Data sourced from ClinicalTrials.gov (NCT04325906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.